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Cited by 316Diabetes, Cardiovascular Risks, and LipoproteinsPhysical Activity and HealthDiabetes Management and Research

The DOI matches its Crossref record; 231 of the 231 references it cites were found in a registry or an index; none of the 245 sources its claims cite is checked for support yet.

Diet, physical activity or both for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus

Open access
Hemmingsen, Bianca, Gimenez-Perez, Gabriel, Mauricio, Didac, Roqué i Figuls, Marta, Metzendorf, Maria-Inti, Richter, Bernd·2017·Cochrane Database of Systematic Reviews
DOI 10.1002/14651858.cd003054.pub4PMC PMC6486271
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Abstract

BACKGROUND: The projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether diet, physical activity or both can prevent or delay T2DM and its associated complications in at-risk people is unknown. OBJECTIVES: To assess the effects of diet, physical activity or both on the prevention or delay of T2DM and its associated complications in people at increased risk of developing T2DM. SEARCH METHODS: This is an update of the Cochrane Review published in 2008. We searched the CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, ICTRP Search Portal and reference lists of systematic reviews, articles and health technology assessment reports. The date of the last search of all databases was January 2017. We continuously used a MEDLINE email alert service to identify newly published studies using the same search strategy as described for MEDLINE up to September 2017. SELECTION CRITERIA: We included randomised controlled trials (RCTs) with a duration of two years or more. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology for data collection and analysis. We assessed the overall quality of the evidence using GRADE. MAIN RESULTS: We included 12 RCTs randomising 5238 people. One trial contributed 41% of all participants. The duration of the interventions varied from two to six years. We judged none of the included trials at low risk of bias for all 'Risk of bias' domains.Eleven trials compared diet plus physical activity with standard or no treatment. Nine RCTs included participants with impaired glucose tolerance (IGT), one RCT included participants with IGT, impaired fasting blood glucose (IFG) or both, and one RCT included people with fasting glucose levels between 5.3 to 6.9 mmol/L. A total of 12 deaths occurred in 2049 participants in the diet plus physical activity groups compared with 10 in 2050 participants in the comparator groups (RR 1.12, 95% CI 0.50 to 2.50; 95% prediction interval 0.44 to 2.88; 4099 participants, 10 trials; very low-quality evidence). The definition of T2DM incidence varied among the included trials. Altogether 315 of 2122 diet plus physical activity participants (14.8%) developed T2DM compared with 614 of 2389 comparator participants (25.7%) (RR 0.57, 95% CI 0.50 to 0.64; 95% prediction interval 0.50 to 0.65; 4511 participants, 11 trials; moderate-quality evidence). Two trials reported serious adverse events. In one trial no adverse events occurred. In the other trial one of 51 diet plus physical activity participants compared with none of 51 comparator participants experienced a serious adverse event (low-quality evidence). Cardiovascular mortality was rarely reported (four of 1626 diet plus physical activity participants and four of 1637 comparator participants (the RR ranged between 0.94 and 3.16; 3263 participants, 7 trials; very low-quality evidence). Only one trial reported that no non-fatal myocardial infarction or non-fatal stroke had occurred (low-quality evidence). Two trials reported that none of the participants had experienced hypoglycaemia. One trial investigated health-related quality of life in 2144 participants and noted that a minimal important difference between intervention groups was not reached (very low-quality evidence). Three trials evaluated costs of the interventions in 2755 participants. The largest trial of these reported an analysis of costs from the health system perspective and society perspective reflecting USD 31,500 and USD 51,600 per quality-adjusted life year (QALY) with diet plus physical activity, respectively (low-quality evidence). There were no data on blindness or end-stage renal disease.One trial compared a diet-only intervention with a physical-activity intervention or standard treatment. The participants had IGT. Three of 130 participants in the diet group compared with none of the 141 participants in the physical activity group died (very low-quality evidence). None of the participants died because of cardiovascular disease (very low-quality evidence). Altogether 57 of 130 diet participants (43.8%) compared with 58 of 141 physical activity participants (41.1%) group developed T2DM (very low-quality evidence). No adverse events were recorded (very low-quality evidence). There were no data on non-fatal myocardial infarction, non-fatal stroke, blindness, end-stage renal disease, health-related quality of life or socioeconomic effects.Two trials compared physical activity with standard treatment in 397 participants. One trial included participants with IGT, the other trial included participants with IGT, IFG or both. One trial reported that none of the 141 physical activity participants compared with three of 133 control participants died. The other trial reported that three of 84 physical activity participants and one of 39 control participants died (very low-quality evidence). In one trial T2DM developed in 58 of 141 physical activity participants (41.1%) compared

Overview

AI snapshot

Written from a shortened version of the paper’s full text (it is longer than we read).

TL;DR

This Cochrane review update found moderate-quality evidence that diet plus physical activity reduces or delays type 2 diabetes in people with impaired glucose tolerance, but there is no firm evidence that diet alone or physical activity alone affects type 2 diabetes risk or its complications. Data on patient-important outcomes such as mortality, cardiovascular events, microvascular complications, and quality of life remain sparse.

Key findings

  • In 11 trials comparing diet plus physical activity with standard or no treatment, T2DM developed in 315 of 2122 intervention participants (14.8%) versus 614 of 2389 comparator participants (25.7%) (RR 0.57, 95% CI 0.50 to 0.64; 4511 participants; moderate-quality evidence).
  • All-cause mortality was 12 deaths in 2049 diet-plus-physical-activity participants versus 10 in 2050 comparator participants (RR 1.12, 95% CI 0.50 to 2.50; 4099 participants, 10 trials; very low-quality evidence). Cardiovascular mortality was 4 of 1626 versus 4 of 1637 (RR 0.94, 95% CI 0.24 to 3.65; 3263 participants, 7 trials; very low-quality evidence).
  • One trial compared diet only with physical activity only in participants with IGT: 57 of 130 diet participants (43.8%) versus 58 of 141 physical activity participants (41.1%) developed T2DM; 3 of 130 diet participants versus none of 141 physical activity participants died (very low-quality evidence).
  • Two trials compared physical activity with standard treatment in 397 participants: one reported T2DM in 58 of 141 physical activity participants (41.1%) versus 90 of 133 controls (67.7%); the other reported 10 of 84 (11.9%) versus 7 of 39 (18%) (very low-quality evidence).

Methods

  • Systematic review and meta-analysis; update of a Cochrane Review published in 2008. Searches included CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, ICTRP, and reference lists, with the last database search in January 2017 and MEDLINE alerts through September 2017.
  • Included 12 RCTs randomising 5238 people at increased risk of T2DM, defined by intermediate hyperglycaemia/prediabetes. Interventions were diet, physical activity, or both versus standard treatment or no intervention, with a minimum intervention duration of two years; pharmacological intervention trials were excluded.
  • Ten trials were parallel RCTs and two were cluster-randomised. Analyses used random-effects meta-analysis with risk ratios or mean differences, 95% prediction intervals, trial sequential analysis, and GRADE assessment.

Limitations

  • The paper states that none of the included trials was at low risk of bias for all domains; most outcomes were low- or very low-quality evidence, and reporting on patient-important outcomes was insufficient. It also states that the diagnosis of intermediate hyperglycaemia varied across trials, results may not apply to people defined by other glycaemic categories or to children/adolescents, and only four investigators provided additional data.
  • The paper states that many included trials were not designed or powered to detect the review’s predefined patient-important outcomes, individual participant data were unavailable, and funnel plots could not be drawn for most outcomes. Review authors were not blinded during data extraction.
  • Evident from the text: three trials contributed about 70% of all data, and one trial contributed 41% of all participants; most trials included people with IGT, with little evidence for IFG or elevated HbA1c; interventions and diagnostic criteria were heterogeneous; and complications such as blindness, end-stage renal disease, and non-fatal myocardial infarction/stroke were rarely or not reported.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1002/14651858.cd003054.pub4

Cites

231 of 231 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Verification

Claims the paper makes

0 of 245 cited sources checked · 0 supported · 0 flagged

Show all 350 claims

  • It may state two separate claims as one. 86
  • Probably not a substantial claim. 243
  • The quote only partly states this claim. 3
305 of 305

  • The paper relies on this without support.

    The projected rise in the incidence of type 2 diabetes mellitus could develop into a substantial health problem worldwide.

    “The projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide.”

  • The paper relies on this without support.

    People with moderately elevated blood glucose (often referred to as 'prediabetes') are at an increased risk of developing type 2 diabetes.

    “People with moderately elevated blood glucose (often referred to as 'prediabetes') are said to be at an increased risk of developing type 2 diabetes.”

  • The paper relies on this without support.

    It is currently recommended that all people with increased risk of developing type 2 diabetes should adjust their eating habits and physical activity levels.

    “It is currently recommended that all people with increased risk of developing type 2 diabetes should adjust their eating habits and physical activity levels.”

  • The paper relies on this without support.

    The most commonly used criteria to define people with a high risk of developing T2DM were established by the American Diabetes Association (ADA) and the World Health Organization (WHO).

    “The most commonly used criteria to define people with a high risk of developing T2DM were established by the American Diabetes Association (ADA) and the World Health Organization (WHO).”

  • The paper relies on this without support.

    The risk of progression from 'prediabetes' to T2DM depends on the diagnostic criteria used to identify 'prediabetes'.

    “The risk of progression from 'prediabetes' to T2DM depends on the diagnostic criteria used to identify 'prediabetes'.”

  • The paper relies on this without support.

    Some people diagnosed with 'prediabetes' will never develop T2DM, and some will return to normoglycaemia.

    “Some people diagnosed with 'prediabetes' will never develop T2DM, and some will return to normoglycaemia.”

  • The paper relies on this without support.

    IGT is often accepted as the best glycaemic variable for 'prediabetes' to predict progression to T2DM.

    “IGT is often accepted as the best glycaemic variable for 'prediabetes' to predict progression to T2DM.”

  • The paper relies on this without support.

    Less than half of the people defined as prediabetic by means of IGT will develop T2DM in the following 10 years.

    “However, studies indicate that less than half of the people defined as prediabetic by means of IGT will develop T2DM in the following 10 years.”

  • The paper relies on this without support.

    Nutritional advice usually consists of caloric restriction in overweight people, low total fat content (especially saturated fat) and high (predominantly unrefined) carbohydrate content.

    “Nutritional advice usually consists of caloric restriction in overweight people, low total fat content (especially saturated fat) and high (predominantly unrefined) carbohydrate content.”

  • The paper relies on this without support.

    Physical activity or diet interventions are not generally considered to be associated with any serious adverse event.

    “Physical activity or diet interventions are not generally considered to be associated with any serious adverse event.”

  • The paper relies on this without support.

    Physical activity may cause traumatic injuries of variable severity depending on the type and intensity of physical activity.

    “However, physical activity may cause traumatic injuries of variable severity depending on the type and intensity of physical activity.”

  • The paper relies on this without support.

    Exercising may produce adverse effects on the cardiovascular system in those people with insufficient training or unfavourable cardiovascular fitness (even cardiovascular events and death may potentially occur while exercising).

    “Additionally, exercising may produce adverse effects on the cardiovascular system in those people with insufficient training or unfavourable cardiovascular fitness (even cardiovascular events and death may potentially occur while exercising).”

  • The paper relies on this without support.

    The implementation of dietary measures may produce several deficiencies in nutritional status if restrictive low-calorie diets are used.

    “Also, the implementation of dietary measures may produce several deficiencies in nutritional status if restrictive low-calorie diets are used.”

  • The paper relies on this without support.

    Dieting may reduce quality of life of people under this treatment.

    “Further, dieting may reduce quality of life of people under this treatment.”

  • The paper relies on this without support.

    Differences of glycaemic measurements used to define 'prediabetes' may introduce substantial heterogeneity.

    “Differences of glycaemic measurements used to define 'prediabetes' may introduce substantial heterogeneity.”

  • The paper relies on this without support.

    Heterogeneity is likely to increase when future trials are included.

    “as heterogeneity is likely to increase when future trials are included”

  • The authors state this as an assumption.

    The independent end-points committee that confirmed newly diagnosed cases of diabetes in DPS 2001 was blinded.

    “Not described whether this committee was blinded.We assume that the outcome committee was blinded”
17 of 17

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • IFG control-group diabetes percentage is incorrect

    Minor

    Two of 21 participants is 9.5%, not the reported 7.8%.

    Reported 7.8 · recomputed 9.52381

  • Cluster-adjusted physical-activity denominator differs between comparisons

    Minor

    The same Da Qing physical-activity group and its 58 diabetes cases are adjusted to 33/84 in one comparison but 33/81 in another.

  • Conflicting total of included trials in risk-of-bias discussion

    Minor

    The review repeatedly states that 12 trials were included, but this passage refers to 11 included trials.

  • Control-group diabetes cases exceed the reported total

    Minor

    The control-group glycaemic subgroups report five, two and four participants developing T2DM, summing to 11, although the trial total is seven.

    Reported 7 · recomputed 11

  • Physical-activity subgroup diabetes cases exceed the reported total

    Minor

    The three physical-activity glycaemic subgroups report seven, three and two T2DM cases, summing to 12 rather than the reported 10.

    Reported 10 · recomputed 12

  • Conflicting Da Qing IGT glucose thresholds

    Minor

    One section describes Da Qing's WHO 1985 two-hour glucose lower threshold as 6.7 mmol/L; another explicitly includes Da Qing among trials using a threshold of 7.8 mmol/L.

  • Number of trials reporting intervention costs conflicts

    Minor

    The abstract reports costs from three trials and 2755 participants, whereas the summary-of-findings entry reports four trials and 2775 participants.

  • Control-group subgroup size is misstated

    Minor

    The control group's mutually exclusive baseline glycaemic subgroups contain 15, 21 and six participants, totalling 42-not the stated 32. This also exceeds the reported control-group size of 39.

    Reported 32 · recomputed 42

  • Mortality estimate lies outside its stated confidence interval

    Minor

    The reported mortality rate of 2.2 per 1000 person-years is outside its stated 95% confidence interval, whose endpoints are also reversed.

9 of 9

Citations

Cites

Items 201–231 of 231

Flagged first, then by citations

Research works printed but not linked: 18

  1. Diabetes Prevention Program (DPP) Research Group, 2009, 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study, Lancet, 374, 2054
  2. Ma, 2014, Physical function decline in the diabetes prevention program outcome study, Diabetes, 63, A344
  3. The Diabetes Prevention Program Research Group, 2003, Within-trial cost-effectiveness of lifestyle intervention or metformin for the primary prevention of type 2 diabetes, Diabetes Care, 26, 2518, 10.2337/diacare.26.9.2518 · DOI
  4. Penn, 2013, Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT, PloS One, 8, e57143, 10.1371/journal.pone.0057143 · DOI
  5. Penn, 2013, Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT, PloS One, 8, e57143, 10.1371/journal.pone.0057143 · DOI
  6. Rosa, 2007, Detecting and managing metabolic syndrome: preliminary results, Ethnicity and Disease, 17, 24
  7. Vlaar, 2012, Feasibility and effectiveness of a targeted diabetes prevention program for 18 to 60-year-old South Asian migrants: design and methods of the DH!AAN study, BMC Public Health, 12, 371, 10.1186/1471-2458-12-371 · DOI
  8. Tao, 2004, Effect of exercise training in patients with impaired glucose tolerance, Zhongguo Linchuang Kangfu, 8, 2912
  9. Fogelholm, 2015, PREVIEW-Design, methods and baseline participant description of an international intervention to prevent type-2 diabetes, Annals of Nutrition and Metabolism, 67, 414
  10. Raben A Fogelholm M Larsen TM Drummens M Poppitt S Formiguera JA PREVIEW: Prevention of diabetes through lifestyle intervention and population studies in Europe and a round the world. Over 2,000 volunteers randomized to the 3-y RCT Obesity Facts Conference: 22nd Congress of the European Congress on Obesity, ECO 2015 Prague Czech Republic 2015 126
  11. Knowler, 2002, Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin, New England Journal of Medicine, 346, 393, 10.1056/nejmoa012512 · DOI · Paper page
  12. Tuomilehto, 2001, Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance, New England Journal of Medicine, 344, 1343, 10.1056/nejm200105033441801 · DOI · Paper page
  13. Institute for Clinical and Economic Review Diabetes prevention programs: effectiveness and value Final Evidence Report and Meeting Summary July 2016
  14. International Conference on Harmonisation Expert Working Group International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline. Guideline for good clinical practice //1997 CFR & ICH Guidelines PA 19063-2043 USA: Barnett International/PAREXEL, 1997
  15. International Diabetes Federation (IDF), 2013, IDF Diabetes Atlas
  16. Penn, 2013, Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT, PloS One, 8, e57143, 10.1371/journal.pone.0057143 · DOI
  17. Nordic Cochrane Centre, The Cochrane Collaboration Review Manager 5 (RevMan 5) 2014
  18. Schünemann HJ Oxman AD Higgins JPT Vist GE Glasziou P Guyatt GH Chapter 11: Presenting results and ‘Summary of findings' tables. In: Higgins JPT, Green S (editors), Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011 Available from handbook.cochrane.org

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Metadata

Authors
Hemmingsen, B., Gimenez-Perez, G., Mauricio, D., Roqué i Figuls, M., Metzendorf, M.-I., & Richter, B.
Affiliations
  • Herlev Hospital (DK)
  • Hospital General de Granollers and School of Medicine and Health Sciences. Universitat Internacional de Catalunya (UIC); Medicine Department; Francesc Ribas s/n Granollers Spain 08402
  • Hospital Universitari Germans Trias i Pujol - CIBERDEM; Department of Endocrinology and Nutrition; Carretera Canyet S/N Badalona Spain 08916
  • CIBER Epidemiología y Salud Pública (CIBERESP); Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau); Sant Antoni Maria Claret 171 Edifici Casa de Convalescència Barcelona Catalunya Spain 08041
  • Heinrich Heine University Düsseldorf (DE)
ORCID
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2017-12-04
Volume
2017
Issue
12
Pages
CD003054-CD003054
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
DOI
10.1002/14651858.cd003054.pub4
PMC
PMC6486271
OpenAlex
W2771834975
Semantic Scholar
67baf9f281193cf6605ad1a11229ad1484b74c8a
Cited by
316
References
231
Citations by year
2026: 11 · 2025: 39 · 2024: 42 · 2023: 46 · 2022: 56 · 2021: 44 · 2020: 35 · 2019: 22 · 2018: 21
FWCI
3.11
Type
journal article
Language
en
Open access
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, public-domain)
  • LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, public-domain)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Physical Activity and Health
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
type 2 diabetes, diabetes prevention, diabetes prevention programmes, diet, physical activity, impaired glucose tolerance, impaired fasting glucose, diabetes complications, cardiovascular events, mortality, lifestyle intervention, prediabetes
MeSH terms
Cause of Death, Combined Modality Therapy, Diabetes Mellitus, Type 2, Diet, Diabetic, Diet, Fasting, Glucose Tolerance Test, Humans, Risk, Exercise, Incidence, Randomized Controlled Trials as Topic, Diabetes Complications

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