Metabolic Effects of a Caloric Restriction High/Low Glycemic Index Diet Plus Metformin in Overweight/Obese Subjects

Effects of a Caloric Restriction High/Low-glycemic Index Diets and in Combination With Metformin on Glucose Metabolism, Lipid Profile and Body Composition in Overweight/Obese Subjects

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01460797

Enrollment

Registered

2011-10-27

Start date

2004-10-31

Completion date

2006-10-31

Last updated

2011-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Glycemic index, Caloric restriction, Energy intake, Glucose, Lipid Metabolism, Cholesterol, HDL Cholesterol, LDL Cholesterol, Obesity, Metformin

Brief summary

The prevalence of obesity and Type 2 diabetes has increased dramatically worldwide. Research on Glycemic Index (GI) diets has been largely developed, however the combination with metformin in humans was not investigated yet. We hypothesized that the low-GI diet in combination with metformin would elicit greater improvements on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects. This study aims to evaluate the metabolic effects of the adoption of dietary advice to follow caloric restriction high/low GI diets, and low-GI diet associated with metformin on glucose metabolism, lipid profile and body composition on overweight or obese type 1 subjects.

Detailed description

All groups (Low/High-GI and Low-GI + Metformin) showed significant reduction in anthropometric parameters, but only Low-GI and Low-GI + Metformin groups have an improvement in body composition parameters. In addition, the Low-GI group achieved better results in metabolism of carbohydrates (glucose, insulin, Cederholm Index, and HOMA-β) and lipids (Chol, TAG, LDL-C, VLDL-C, and TC/HDL-c). These results show the benefits of Low-GI diet on metabolic parameters in overweight or obese type 1 subjects.

Interventions

OTHERGlycemic Index Diets and Metformin hydrochloride

1g of Metformin hydrochloride a day in High Glycemic Index Diet

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Participants were adults (18-50 y), with body mass index (BMI) between 25-35 kg/m². * Subjects with adequate glycemic and insulinemic response after oral glucose tolerance test: Hypocaloric diet with predominating high glycemic index foods; * Subjects with altered glycemic response presented at the 120 min point either glycemia \<140mg/dL and insulin level \>40 µUI/ml: Hypocaloric diet with predominant low glycemic index foods; * Subjects with impaired glucose tolerance presented at the 120 min point glycemia 140 - 199mg/dL and insulin \>40 µUI/ml: Hypocaloric diet with predominant low glycemic index foods and metformin.

Exclusion criteria

* Smokers * Pregnant or lactating * Diagnosis of any metabolic diseases * Were under medication and therapeutic diet, except oral contraceptive for women.

Design outcomes

Primary

Measure	Time frame	Description
Glucose Metabolism	0 and 4 months	2-hour oral glucose tolerance test (Glucose and Insulin levels), glucose and insulin IAUC, HbA1c, HOMA-IR, HOMA-β, and Cederholm Index.

Secondary

Measure	Time frame	Description
Lipid Profile	0 and 4 months	Cholesterol, TAG, LDL-C, VLDL-C, HDL-c, and Cholesterol/HDL-c ratio
Body Composition	0 and 4 months	Body weight, Height, Body mass index, Body fat mass, Free fat body mass, Waist circumference.
Clinical Assessment	0 and 4 months	FSH hormone, urea, creatinine, and uric acid urinary levels
Food Intake	0 and 4 months	Energy intake, macronutrients and fiber consumption

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026