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Effect of metformin and diet in treatment of metabolic syndrome

Comparison of the effect of low glycemic index diet and metformin drug on metabolic syndrome components in adults with metabolic syndrome.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000148673
Acronym
-
Enrollment
60
Registered
2014-02-06
Start date
2013-08-24
Completion date
2014-02-19
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Metabolic syndrome continues to be highly prevalent and contributes to a rapidly growing problem globally. The most important therapeutic intervention, that its efficacy in metabolic syndrome has been proven, is diet modification. A number of studies have shown that low glycemic index diet have positive effects on patients with MetS . So the goal of this study is to compare the effects of low Glycemic Index diet and metformin drug on MetS components in order to replace the drug by the diet in adults with MetS. This study is a Randomised Clinical Controlled Trial. The including criteria is the age between 25 to 65 years old and having 3 characteristics related to metabolic syndrome according to the Adult Treatment Panel, Not taking any drug that might affect blood pressure and glucose , insulin or lipid metabolism , Not having diabetes, liver or kidney diseases . Patients will be excluded if they get gastrointestinal disorders or not willing to continue the study. The 60 patients will randomly allocated to two group of metformin drug and lowGlycemic Index diet. The intervention period is 8 weeks and at the end of the trial groups will be compared for the following factors: weight , blood pressure , waist circumference, fasting blood sugar and lipid profiles (TG, total cholesterol, LDL, HDL).

Interventions

The 60 patients will randomly allocated to two group of metformin drug and lowGI diet. The dose of administration for the metformin group will be 500mg (1 oral tab daily) for 8 weeks. For the diet group the percentage of requiered energy will be calculated with harris-benedict formula.The percentage of macronutrients are the same for all participants and will be 50% carbohydrate,30%fat and 20%protein.The only difference to normal diet is the use of low-GI foods in the diet plan. The foods will b

The 60 patients will randomly allocated to two group of metformin drug and lowGI diet. The dose of administration for the metformin group will be 500mg (1 oral tab daily) for 8 weeks. For the diet group the percentage of requiered energy will be calculated with harris-benedict formula.The percentage of macronutrients are the same for all participants and will be 50% carbohydrate,30%fat and 20%protein.The only difference to normal diet is the use of low-GI foods in the diet plan. The foods will be chosen from Foster-Powel Table ,will medium (55-70) and low(less than 55) glycemic index. we will make a phone call in every 2weeks for monitoring the patients. The intervention period for both groups is 8 weeks.

Sponsors

Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
25 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Having 3 characteristics related to metabolic syndrome according to the Adult Treatment Panel, Not taking any drug that might affect blood pressure and glucose , insulin or lipid metabolism , Not having diabetes, liver or kidney diseases.

Exclusion criteria

Patients will excluded if they get gastrointestinal disorders or not willing to continue the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026