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Cited by 176Diet and metabolism studiesDiabetes Management and ResearchDietary Effects on Health

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A Novel Intervention Including Individualized Nutritional Recommendations Reduces Hemoglobin A1c Level, Medication Use, and Weight in Type 2 Diabetes

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McKenzie, Amy L, Hallberg, Sarah J, Creighton, Brent C, Volk, Brittanie M, Link, Theresa M, Abner, Marcy K, Glon, Roberta M, McCarter, James P, Volek, Jeff S, Phinney, Stephen D·2017·JMIR Diabetes
DOI 10.2196/diabetes.6981PMC PMC6238887
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Abstract

BACKGROUND: Type 2 diabetes (T2D) is typically managed with a reduced fat diet plus glucose-lowering medications, the latter often promoting weight gain. OBJECTIVE: We evaluated whether individuals with T2D could be taught by either on-site group or remote means to sustain adequate carbohydrate restriction to achieve nutritional ketosis as part of a comprehensive intervention, thereby improving glycemic control, decreasing medication use, and allowing clinically relevant weight loss. METHODS: ) and related biomarkers of T2D were evaluated at baseline and 10-week follow-up. RESULTS: =1.503, P=.22). CONCLUSIONS: These initial results indicate that an individualized program delivered and supported remotely that incorporates nutritional ketosis can be highly effective in improving glycemic control and weight loss in adults with T2D while significantly decreasing medication use.

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Crossref · 10.2196/diabetes.6981

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Figure 1 Relative frequency distribution of participant weekly average beta-hydroxybutyrate (BOHB) concentrations. An observed weekly average BOHB concentration on the border of 2 bins is placed in the bin holding the larger values. Evidence of carbohydrate restriction exhibited by elevated ketones was present in the first week in the majority of subjects and maintained for the duration of the study. All reported BOHB concentrations greater than 3.0 were in participants taking a sodium-glucose cotransporter-2 inhibitor, except for one (4.4 mmol•L−1) in which we suspect elevated BOHB due to increased exercise and another (6.0 mmol•L−1) in which we suspect participant data entry error. Excluding this 1 value, average BOHB concentrations for this participant ranged from 0.4 to 1.4 mmol•L−1.
Figure 1 Relative frequency distribution of participant weekly average beta-hydroxybutyrate (BOHB) concentrations. An observed weekly average BOHB concentration on the border of 2 bins is placed in the bin holding the larger values. Evidence of carbohydrate restriction exhibited by elevated ketones was present in the first week in the majority of subjects and maintained for the duration of the study. All reported BOHB concentrations greater than 3.0 were in participants taking a sodium-glucose cotransporter-2 inhibitor, except for one (4.4 mmol•L−1) in which we suspect elevated BOHB due to increased exercise and another (6.0 mmol•L−1) in which we suspect participant data entry error. Excluding this 1 value, average BOHB concentrations for this participant ranged from 0.4 to 1.4 mmol•L−1.CC BY · PubMed Central
Figure 2 Hemoglobin A1c (HbA1c) changes by baseline level. Error bars represent SD; the dotted line represents the threshold for diagnosis of type 2 diabetes. Significant reductions in HbA1c level from baseline to follow-up were observed in subjects whose baseline HbA1c level was ≥7.5% (mean 9.0%, SD 1.3% to 7.2%, SD 1.1%, P<.001) and between 6.5% and 7.4% (mean 6.9%, SD 0.3% to 6.2%, SD 0.5%, P<.001). For those whose baseline HbA1c level was <6.5%, HbA1c level was improved but not significantly after correcting for multiple comparisons (mean 6.1%, SD 0.3% to 5.8%, SD 0.4%, P=.03). *Represents significant difference from baseline.
Figure 2 Hemoglobin A1c (HbA1c) changes by baseline level. Error bars represent SD; the dotted line represents the threshold for diagnosis of type 2 diabetes. Significant reductions in HbA1c level from baseline to follow-up were observed in subjects whose baseline HbA1c level was ≥7.5% (mean 9.0%, SD 1.3% to 7.2%, SD 1.1%, P<.001) and between 6.5% and 7.4% (mean 6.9%, SD 0.3% to 6.2%, SD 0.5%, P<.001). For those whose baseline HbA1c level was <6.5%, HbA1c level was improved but not significantly after correcting for multiple comparisons (mean 6.1%, SD 0.3% to 5.8%, SD 0.4%, P=.03). *Represents significant difference from baseline.CC BY · PubMed Central
Figure 3 Frequency of medication dose changes by drug class. Bars represent total users of each drug with the type of dose change (increase, no change, decrease, or elimination) stacked within the bar and the relative frequency noted next to each section. The total number of users is noted at the top of each bar. The proportion of participants who were prescribed the drug was significantly different between baseline and follow-up for insulin (χ21=21.4, P<.001), sulfonylureas (χ21=54.0, P<.001), and sodium-glucose cotranporter-2 (SGLT-2) inhibitors (χ21=17.9, P<.001) but not for dipeptidyl peptidase-4 (DPP-4) inhibitors (χ21=6.9, P=.009), thiazolidinediones (χ21=1.3, P=.25), glucagon-like peptide-1 (GLP-1) receptor agonists (χ21=0.5, P=.50), or metformin (χ21=0.8, P=.36).
Figure 3 Frequency of medication dose changes by drug class. Bars represent total users of each drug with the type of dose change (increase, no change, decrease, or elimination) stacked within the bar and the relative frequency noted next to each section. The total number of users is noted at the top of each bar. The proportion of participants who were prescribed the drug was significantly different between baseline and follow-up for insulin (χ21=21.4, P<.001), sulfonylureas (χ21=54.0, P<.001), and sodium-glucose cotranporter-2 (SGLT-2) inhibitors (χ21=17.9, P<.001) but not for dipeptidyl peptidase-4 (DPP-4) inhibitors (χ21=6.9, P=.009), thiazolidinediones (χ21=1.3, P=.25), glucagon-like peptide-1 (GLP-1) receptor agonists (χ21=0.5, P=.50), or metformin (χ21=0.8, P=.36).CC BY · PubMed Central
Figure 4 Hemoglobin A1c (HbA1c) level at baseline and 10-11 weeks per change in insulin dosage. Insulin users who were able to eliminate or reduce their use of the drug also significantly reduced their HbA1c level (7.9%, SD 1.5%, to 6.6%, SD 0.9%, P<.001 and 8.8%, SD 1.8%, to 7.4%, SD 1.2%, P<.001, respectively). Six users with no change in insulin dose achieved a reduction in HbA1c level, although it was not statistically significant (8.2%, SD 1.8%, to 7.6%, SD 1.2%, P=.25). Despite an increased insulin dosage in 4 users, HbA1c level increased but the difference was not significant (8.3%, SD 0.4%, to 8.7%, SD 0.8%, P=.61).
Figure 4 Hemoglobin A1c (HbA1c) level at baseline and 10-11 weeks per change in insulin dosage. Insulin users who were able to eliminate or reduce their use of the drug also significantly reduced their HbA1c level (7.9%, SD 1.5%, to 6.6%, SD 0.9%, P<.001 and 8.8%, SD 1.8%, to 7.4%, SD 1.2%, P<.001, respectively). Six users with no change in insulin dose achieved a reduction in HbA1c level, although it was not statistically significant (8.2%, SD 1.8%, to 7.6%, SD 1.2%, P=.25). Despite an increased insulin dosage in 4 users, HbA1c level increased but the difference was not significant (8.3%, SD 0.4%, to 8.7%, SD 0.8%, P=.61).CC BY · PubMed Central
Figure 5 Participant weight loss over 10 weeks. Part “a”—weight change over 10 weeks for all participants. Solid line represents the mean; dotted lines represent one standard deviation from the mean. Part “b”—individual body weight changes as percentage of starting body weight at 10 weeks for completers (n=238). Part “c”—individual body weight changes as percentage of starting body weight for each noncompleter at the time of removal from study. For the 21 dropouts, time to drop out was 6 (SD 3) weeks (n=3 participants are still enrolled in the study but did not complete 10-week follow-up testing).
Figure 5 Participant weight loss over 10 weeks. Part “a”—weight change over 10 weeks for all participants. Solid line represents the mean; dotted lines represent one standard deviation from the mean. Part “b”—individual body weight changes as percentage of starting body weight at 10 weeks for completers (n=238). Part “c”—individual body weight changes as percentage of starting body weight for each noncompleter at the time of removal from study. For the 21 dropouts, time to drop out was 6 (SD 3) weeks (n=3 participants are still enrolled in the study but did not complete 10-week follow-up testing).CC BY · PubMed Central

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  1. Volek, JS, 2011, The Art and Science of Low Carbohydrate Living

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Authors
McKenzie, A. L., Hallberg, S. J., Creighton, B. C., Volk, B. M., Link, T. M., Abner, M. K., Glon, R. M., McCarter, J. P., Volek, J. S., & Phinney, S. D.
Affiliations
Indiana University Health (US)
Corresponding author
Phinney, Stephen D
ORCID
Venue
JMIR Diabetes
Publisher
JMIR Publications Inc.
Published
2017-03-07
Volume
2
Issue
1
Pages
e5
ISSN
2371-4379 (ISSN-L)
DOI
10.2196/diabetes.6981
PMC
PMC6238887
OpenAlex
W2593555386
Cited by
176
References
42
Citations by year
2026: 6 · 2025: 9 · 2024: 33 · 2023: 14 · 2022: 23 · 2021: 25 · 2020: 23 · 2019: 19 · 2018: 19 · 2017: 5
FWCI
13.36
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • JMIR Diabetes (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Physiology (medical) › Diet and metabolism studies
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Physiology (medical) › Dietary Effects on Health
Keywords
type 2 diabetes, nutritional ketosis, carbohydrate restriction, glycemic control, HbA1c, weight loss, medication reduction, remote intervention, group intervention, diabetes self-management

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