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

Obesity Clinical Trial

Official title:

Effect of Metformin ER With Hypocaloric Diet on Weight Loss in Overweight/Obese Patients With Increased Waist Circumference

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949008
• Other study ID #: 22-001670
• Status: Recruiting
• Phase: Phase 4
• Start date: November 22, 2023
• Est. completion date: July 30, 2027

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: Gail Thames, BA
• Phone: 310-825-0453
• Email: Gthames[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 30, 2027
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• NIDDM
• Obesity

Intervention

Drug:
• Metformin Extended Release (ER) Oral Tablet
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
Matching placebo will be provided as 1000 mg capsules

Locations

Country	Name	City	State
United States	UCLA Center for Human Nutrition	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who achieve body weight reduction =5% from baseline	Percent change in body weight reduction =5% from baseline (week 0) to week 24.	24 Weeks
Primary	Change in total body weight from baseline	Percent change in total body weight (TBW) from baseline (week 0) to week 24 in body weight.	24 Weeks
Secondary	Change in total Body Mass Index (BMI) from baseline	Change from baseline (week 0) to week 24 in: BMI	24 Weeks
Secondary	Change in insulin sensitivity from baseline	Change from baseline (week 0) to week 24 in Insulin sensitivity	24 Weeks
Secondary	Change in fasting blood lipids from baseline	Change from baseline (week 0) to week 24 in Fasting blood lipids	24 Weeks
Secondary	Change in waist circumference from baseline	Change from baseline (week 0) to week 24 in:Waist circumference (cm)	24 weeks
Secondary	Percent change in % body fat from baseline	Change from baseline (week 0) to week 24 in: body fat (%).	24 weeks