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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460797
• Other study ID #: Glycemic index and Metformin
• Status: Completed
• Phase: N/A
• First received: October 17, 2011
• Last updated: October 25, 2011
• Start date: October 2004
• Est. completion date: October 2006

Study information

• Verified date: October 2011
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2006
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Glycemic Index Diets and Metformin hydrochloride
1g of Metformin hydrochloride a day in High Glycemic Index Diet

Locations

Country	Name	City	State
Brazil	School of Health Sciences, University of Brasília	Brasília	DF

Sponsors (4)

Lead Sponsor	Collaborator
Caio Eduardo Gonçalves Reis	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fund to support research of the Federal District, Brazil, University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Metabolism	2-hour oral glucose tolerance test (Glucose and Insulin levels), glucose and insulin IAUC, HbA1c, HOMA-IR, HOMA-ß, and Cederholm Index.	0 and 4 months	No
Secondary	Lipid Profile	Cholesterol, TAG, LDL-C, VLDL-C, HDL-c, and Cholesterol/HDL-c ratio	0 and 4 months	No
Secondary	Body Composition	Body weight, Height, Body mass index, Body fat mass, Free fat body mass, Waist circumference.	0 and 4 months	No
Secondary	Clinical Assessment	FSH hormone, urea, creatinine, and uric acid urinary levels	0 and 4 months	No
Secondary	Food Intake	Energy intake, macronutrients and fiber consumption	0 and 4 months	No