Clinical trial NCT05949008: Effect of Metformin, a Drug Used to Treat Diabetes, vs Placebo
Official title: Effect of Metformin ER With Hypocaloric Diet on Weight Loss in Overweight/Obese Patients With Increased Waist Circumference
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: NIDDM
Obesity
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to placebo or Metformin.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Obesity is a growing epidemic in the United States. Weight gain is associated with an increased risk of developing life-threatening conditions such as high blood pressure or diabetes. Therefore, there is great interest in developing non-invasive treatments to help combat obesity. Currently, there are only few weight-loss drugs available for the treatment of obesity. In the more recent past, GLP-1 analogues (a type of non-insulin medication used to treat patients with diabetes) are being promoted as a new strategy to lose weight without major side effects however, with high costs and challenging supply chain issues.

This is a double-blinded, randomized study. This means that participants will be assigned to one of two groups. Participants will have a 1:1 chance of being assigned to receive either the study drug or a placebo (a capsule that does not contain the active ingredients). This assignment will be determined by chance. The process is similar to drawing cards or picking straws. This means your assignment to one of the groups is based on chance and not a medical decision made by the study doctor. In addition, neither participants nor the investigators will know what groups participants have been assigned to.

During this study, your participation will last up to 26 weeks (including screen) with a total of 8 clinic visits. Participants will undergo a total of 5 blood draws, blood samples will be taken at screen baseline and weeks 8, 16 and 24.

Eligibility 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

Primary outcomes:
measure: Number of participants who achieve body weight reduction ≥5% from baseline
timeFrame: 24 Weeks
measure: Change in total body weight from baseline
timeFrame: 24 Weeks
Secondary outcomes:
measure: Change in total Body Mass Index (BMI) from baseline
timeFrame: 24 Weeks
measure: Percent change in body composition from baseline
timeFrame: 24 weeks
measure: Change in waist circumference from baseline
timeFrame: 24 weeks
measure: Change in insulin sensitivity from baseline
timeFrame: 24 Weeks
measure: Change in fasting blood lipids from baseline
timeFrame: 24 Weeks
measure: Change in vascular function parameters (blood pressure and pulse wave velocity)
timeFrame: 24 weeks
measure: Change in inflammatory markers from baseline
timeFrame: 24 weeks
measure: Change in daily dietary intake (calories and macronutrients)
timeFrame: 24 weeks
measure: Change in physical activity levels from baseline
timeFrame: 24 weeks
measure: Change in quality of life from baseline
timeFrame: 24 weeks
measure: Change in glycemic control
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutrition
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Vijiya Surampudi, MD
role: PRINCIPAL_INVESTIGATOR
References: