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Completed

NCT Number: NCT04148183

Effect of Metformin and Rosiglitazone Over no Diabetic With Metabolic Syndrome Patients.

To compare the effect of insulin sensitizing drugs (metformin and rosiglitazone) over glucose homeostasis (GH) in no diabetic metabolic syndrome individuals. A randomized blinded clinical trial did in patients with metabolic syndrome (n=30), without diabetes. Prior to detailed information and signature of informed consent by patients were done three treatment groups by randomized technique; a) Placebo, b) Metformin (850 mg/day), c) Rosiglitazone (4 mg/day), treatment was administered for 8 weeks. GH was measured before and after treatment using oral glucose tolerance test (OGTT), and IR-index (Homeostatic Model). Determination was performed on weight, size, body mass index, plicometry, blood pressure, fasting glucose levels, triglycerides, HDL-cholesterol and insulin.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

Metabolic syndrome is a risk factor for diabetes mellitus characterized by insulin resistance, hypertension, triglyceride elevation, low levels of high-density lipoproteins, and obesity. Metformin and rosiglitazone are two insulinosensensitizers used in the treatment of diabetes. Now there is controversy over the use of insulinossensitizers in non-diabetic patients with metabolic syndrome. To compare the effect of insulin sensitizing drugs (metformin and rosiglitazone) over glucose homeostasis (GH) in no diabetic metabolic syndrome individuals. Randomized blinded clinical trial in patients with metabolic syndrome without diabetes was done, sample size (n=30). Prior to detailed information and signature of informed consent by patients was randomized forming three treatment groups, a) Placebo, b) Metformin (850 mg/day), c) Rosiglitazone (4 mg/day), treatment was administered for 8 weeks. GH was measured before and after treatment using oral glucose tolerance test (OGTT), and IR-index (Homeostatic Model). Determination was performed on weight, size, body mass index, plicometry, blood pressure, fasting glucose levels, triglycerides, HDL-cholesterol and insulin. Statistic no parametric (Kruskal Wallis, Wilcoxon, U Mann Whitney) to compare characteristics inter o intra groups was done. Exact Fisher test was used for qualitative variable, and consider significance with p<0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years old.
  • Metabolic Syndrome criteria of World Health Organization .

Exclusion criteria

  • Diabetes Mellitus
  • Allergic to Metformin,
  • Allergic to rosiglitazone.
  • Hepatic disease.
  • Hearth disease.

Treatment and study plan

Metformin Group

Drug

We add treatment with Metformin (850 mg/day), treatment was administered for 8 weeks

Other names: Metformina

Rosiglitazone group

Drug

we add Rosiglitazone (4 mg/day), treatment was administered for 8 weeks

Other names: Rosiglitazona

Placebo oral tablet

Drug

We add Placebo, treatment was administered for 8 weeks

Other names: Control Group

Primary outcomes

  1. INSULIN RESISTANCE

    Time frame: 8 weeks

    INSULIN RESISTANCE index (Homeostatic Model) is method that need insulin concentration and glucose in blood to calculate index.

Secondary outcomes

  1. oral glucose tolerance test (OGTT),

    Time frame: 8 weeks

    oral glucose tolerance test was done take a sample of blood before a period without feed of 8 hours, we took a blood glucose sample then we gave a 75g of glucose and after we took blood glucose at the hour and 2 hours of OGTT test

Sponsors and collaborators

Lead sponsor

J JESUS VENEGAS, MD

Other

Collaborators

  • Instituto Mexicano del Seguro Social
  • National Council of Science and Technology, Mexico

Registry information

Official study title

Randomized Clinical Trial, Effect of Metformin and Rosiglitazone Over Glucose Homeoastasis in no Diabetic With Metabolic Syndrome Patients.

Important dates

Study start
2004
Primary completion
2005
Study completion
2009
First posted
Nov 1, 2019
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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