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Recruiting NCT07297290

Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People (MOWRI)

Phase III Interventional Obesity and Cardiovascular Risk Insulin Resistance Obesity (Body Mass Index >30 kg/m2)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin, Placebo.
Who it may be relevant to
Registry conditions: Obesity and Cardiovascular Risk, Insulin Resistance, Obesity (Body Mass Index >30 kg/m2). Basic parameters: 20 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Nigeria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People

Overview

Obesity is a chronic disease of global public health concern, contributing to cardiovascular disease, type 2 diabetes and certain cancers. Currently approved anti-obesity drugs and surgery are expensive and not readily available in Nigeria. Metformin, approved for type 2 diabetes, has been shown to promote weight loss among obese patients in high income countries. However, metformin's effects have not yet been demonstrated in Black African populations, which may have different genetic and environmental predispositions to obesity and to the effect of metformin. This blinded, placebo-controlled, randomized trial is determining the effect of metformin on weight loss, cardiovascular disease risk and insulin resistance in Black Nigerians.

Interventions

  • Drug Metformin
    Metformin 500mg extended release tablets taken to a maximum of 1500mg once daily
  • Drug Placebo
    Starch-based, identical looking placebo

Primary outcome measures

  • Effect of Metformin on body weight change [Time frame: 24 months]
  • Effect of Metformin on Cardiovascular risk [Time frame: 24 months]
  • Effect of Metformin on insulin resistance in non-diabetics [Time frame: 24 months]
  • Effect of metformin on waist circumference change [Time frame: 24 months]
  • Effect of metformin on waist-to-hip circumference change [Time frame: 24 months]
Secondary outcome measures (2)
  • Safety of Metformin extended release tablet taken daily [Time frame: 24 months]
  • Percent drug compliance to Metformin extended release taken once daily. [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • • Obesity (defined as body mass index ≥ 30kg/m2),
  • Fasting plasma glucose (<7.0mmol/L)
  • No medical treatment for weight control in the previous 12 months
  • No participation in a current clinical trial

Exclusion criteria

  • • Obesity (defined as body mass index ≥ 30kg/m2),
  • Fasting plasma glucose (<7.0mmol/L)
  • No medical treatment for weight control in the previous 12 months
  • No participation in a current clinical trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Nigeria · 2 centers
  • Pathology Facility — Enugu
  • University of Nigeria Teaching Hospital — Enugu

Identifiers

NCT: NCT07297290 · 2024CWR-LMIC-981332295

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗