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Cited by 30Berberine and alkaloids researchNatural Antidiabetic Agents StudiesDiabetes Treatment and Management

Efficacy and safety of HIMABERB® berberine on glycemic control in patients with prediabetes: double-blind, placebo-controlled, and randomized pilot trial

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Panigrahi, Antarmayee, Mohanty, Susant·2023·BMC Endocrine Disorders
DOI 10.1186/s12902-023-01442-yPMC PMC10483788

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Abstract

Background: Prediabetes and diabetes involve alterations in glucose homeostasis, including increased fasting blood glucose and impaired glucose tolerance. Berberine has been identified as a potential regulator of glucose homeostasis with implications on the management of type 2 diabetes mellitus (DM). Given a paucity of data on berberine in prediabetes, evaluation of its effect in individuals with prediabetes may prove clinically valuable. Objective: The present pilot study aimed to investigate the effect of daily oral berberine on markers of glycemic control and insulin resistance among individuals with prediabetes. Methods: A randomized, double-blinded, placebo-controlled trial was conducted for 12 weeks among 34 individuals with prediabetes as defined by the American Diabetes Association (fasting plasma glucose (FPG) between 5.6 and 6.9 mmol/L, glycosylated hemoglobin (HbA 1c ) between 5.7% and 6.4%, or 2-hour 75-gram oral glucose tolerance test (2 h-OGTT) between 7.8 and 11.1 mmol/L). HIMABERB® 500 mg was given three times daily to the treatment group, and placebo was administered three times daily to the control group. Glycemic control markers and physical parameters were evaluated for both groups on days 0, 28, 56, and 84. The glycemic control markers assessed included FPG, fasting insulin (FI), 2 h-OGTT, HbA 1c , and homeostatic model assessment-insulin resistance (HOMA-IR). The observed outcomes were analyzed using independent t-test statistics to determine the significance of differences over time after treatment initiation and between treatment and control groups. Results: Significant decreases in all markers of glycemic control were observed in the treatment group at intermediate time points and the endpoint of the study compared to baseline levels and to the control group. For the treatment group, FPG decreased from 6.75 ± 0.23 mmol/L to 5.33 ± 0.28 mmol/L, FI from 9.81 ± 0.36 to 7.88 ± 0.52 mmol/L, 2 h-OGTT from 10.44 ± 0.52 to 8.12 ± 0.40 mmol/L, HbA 1c from 6.40% ± 0.20–5.43% ± 0.21%, and HOMA-IR from 3.61 ± 0.31 to 2.41 ± 0.14. The decreases in glycemic control markers compared to the control group were clinically and statistically significant (p<10 − 5 ). No severe adverse effects, kidney or liver toxicity were detected. Conclusion: After 12 weeks, berberine (HIMABERB®) intervention in individuals with prediabetes significantly reduced glycemic control markers, with mean FPG and 2 h-OTGG being reduced to below prediabetic thresholds, supporting the investigation of the use of HIMABERB® for delaying progression to diabetes mellitus. Trial registration: http://ctri.nic.in (CTRI/2021/12/038751) (20/12/2021) .

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Sorted by citations

Authors
Panigrahi, A., & Mohanty, S.
Affiliations
Siksha O Anusandhan University (IN)
Corresponding author
Panigrahi, Antarmayee
ORCID
Mohanty, Susant
Venue
BMC Endocrine Disorders
Publisher
Springer Science and Business Media LLC
Published
2023-09-07
Volume
23
Issue
1
Pages
190-190
ISSN
1472-6823 (ISSN-L)
DOI
10.1186/s12902-023-01442-y
PMC
PMC10483788
OpenAlex
W4386511003
Cited by
30
References
3
Citations by year
2026: 12 · 2025: 12 · 2024: 6
FWCI
4.67
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Endocrine Disorders (publishedVersion, cc-by)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Health Sciences › Medicine › Pharmacology › Berberine and alkaloids research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Natural Antidiabetic Agents Studies
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords
berberine, prediabetes, glycemic control, insulin resistance, type 2 diabetes, fasting blood glucose, HbA1c, oral glucose tolerance test, HOMA-IR, fasting insulin, herbal supplements, glucose homeostasis, impaired glucose tolerance, impaired fasting glucose, adverse events, pilot study
MeSH terms
Glycemic Control, Berberine, Diabetes Mellitus, Type 2, Double-Blind Method, Glucose, Humans, Insulin, Insulin Resistance, Pilot Projects, Prediabetic State

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