Clinical trial

Effect of Metformin, a Drug Used to Treat Diabetes, vs Placebo

Active, not recruiting · Phase 4 · 1 countries · Registry ID NCT05949008

Active, not recruitingPhase 4Interventional

What this study is about

Metformin is a drug used to treat patients with diabetes. The aim of this study is to examine the effect of Metformin along with a low-calorie diet on obese and/or overweight adults with an increased waist measurement. In addition, the study also aims to look at the effect of the drug vs. placebo on quality of life and physical activity.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionNIDDM, Obesity

Full registry criteria

Inclusion Criteria: * Male or female, age ≥ 18 years at the time of signing informed consent. * Body Mass Index (BMI) ≥ 27 kg/m2 * Waist circumference \>40" for men, and \>35" for women Exclusion Criteria: * A self-reported change in body weight \> 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Diagnosed with T2D (HbA1c \>7.5 (53 mmol/mol) * Current use of insulin or oral medication of metformin, SU, SGLT2i, glitazone, DPP4 or GLP-1 agonist injections as single agent therapy or combination oral agents. * Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of \< 45 mL/min/1.73 m2 (\< 60 ml/min/1.73 m2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 201242 by the central laboratory at screening * History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months (History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable). * History or lactic acidosis * Liver problems * Congestive heart failure * History of alcoholism * Recent surgery * Heart attack, severe infection or stroke * Any unstable medical conditions or terminal diagnosis * Pregnancy or lactation * Allergy and intolerance to metformin

Treatments and study arms

Metformin Extended Release (ER) Oral Tablet

Drug

Metformin ER will be provided as 1000 mg capsules by Qingdao Baheal Pharmaceutical Co., Ltd. In addition to the active ingredient metformin HCl,each tablet contains the following inactive ingredients: Povidone, Sodium Lauryl Sulfate, Magnesium Stearate, Cellulose Acetate, Polyethylene Glycol (PEG 400, PEG 8000), Triacetin, Hypromellose, Titanium Dioxide, Polysorbate 80, Ferrosoferric Oxide, Shellac.

Placebo

Drug

Matching placebo will be provided as 1000 mg capsules

Primary outcomes

Number of participants who achieve body weight reduction ≥5% from baseline24 Weeks

Percent change in body weight reduction ≥5% from baseline (week 0) to week 24.

Change in total body weight from baseline24 Weeks

Percent change in total body weight (TBW) from baseline (week 0) to week 24 in body weight.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

UCLA Center for Human Nutrition🇺🇸 Los Angeles, California, United States