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Anti-diabetic drug
Metformin for Obesity
Phase 4
Recruiting
Led By Vijiya Surampudi, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial aims to see if metformin, combined with a low-calorie diet, helps reduce weight and improve quality of life in obese/overweight adults.
Who is the study for?
Adults over 18 with obesity, specifically those with a waist size over 40 inches for men and over 35 inches for women, and a BMI of at least 27. Participants must not have had recent severe health events like heart attacks or strokes, any unstable conditions, allergies to metformin, poorly controlled diabetes (HbA1c >7.5), significant kidney issues (eGFR <45 mL/min/1.73 m2), thyroid disease without stable treatment for the past six months, weight changes greater than 11 pounds in the last three months, certain diabetes medications use including insulin or oral metformin, history of lactic acidosis or liver problems.Check my eligibility
What is being tested?
The trial is testing Metformin Extended Release tablets against placebo pills to see if they help reduce waist circumference when combined with a low-calorie diet in overweight adults. It also examines how Metformin affects quality of life and physical activity levels compared to the placebo.See study design
What are the potential side effects?
Metformin can cause digestive issues such as stomach pain, diarrhea; it may also lead to vitamin B12 deficiency long-term. Rarely it could cause a serious condition called lactic acidosis where too much acid builds up in the blood.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in total body weight from baseline
Number of participants who achieve body weight reduction ≥5% from baseline
Secondary outcome measures
Change in fasting blood lipids from baseline
Change in insulin sensitivity from baseline
Change in total Body Mass Index (BMI) from baseline
+2 moreSide effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Metformin Extended Release (ER) Oral TabletsExperimental Treatment1 Intervention
This is a 24-week, randomized, double-blinded, two arm parallel clinical trial comparing metformin ER vs. placebo in combination with a hypocaloric diet (-500 kcal/day). 150 individuals with obesity and increased waist circumference will be randomized to taking metformin ER with hypocaloric diet or placebo with hypocaloric diet. All patients will receive dietary and exercise counseling with the intent of reducing their average caloric intake by 500 kcal/day.
Group II: PlaceboPlacebo Group1 Intervention
Patients in the placebo arm will be randomized to placebo with hypocaloric diet. All patients will receive dietary and exercise counseling with the intent of reducing their average caloric intake by 500 kcal/day.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,532 Previous Clinical Trials
10,265,118 Total Patients Enrolled
18 Trials studying Diabetes Mellitus
35,868 Patients Enrolled for Diabetes Mellitus
Vijiya Surampudi, MDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
3 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have liver issues.I have had surgery recently.My kidney function is reduced, with an eGFR below 45 mL/min/1.73 m2.I have lost or gained more than 11 pounds in the last 3 months.I am 18 years or older and have given my consent.I have been diagnosed with congestive heart failure.I have had a heart attack, severe infection, or stroke.My diabetes is not well-controlled (HbA1c >7.5).I am currently taking medication for diabetes, including insulin or pills like metformin.I have a thyroid condition but haven't changed my medication in the last 6 months.I do not have any unstable health conditions or a terminal illness.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin Extended Release (ER) Oral Tablets
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What key goals are this research endeavor aiming to achieve?
"This 24 week long trial will track the amount of total body weight changed since baseline. Additionally, insulin sensitivity, fasting blood lipids and waist circumference are all secondary outcomes that must be monitored to ensure efficacy."
Answered by AI
What potential hazards come with Metformin Extended Release (ER) Oral Tablets?
"Metformin ER Oral Tablets have been approved, so it is assigned a security rating of 3. This evaluation was conducted by Power's team as part of their Phase 4 trial."
Answered by AI
Are new participants being admitted to this experiment?
"This clinical trial is not currently recruiting, as reported on the official listing. The study was initially announced in August of 2023 and adjusted most recently in July of 2023. Although this particular medical experiment has stopped enrolling patients, there are still 993 other trials actively seeking participants."
Answered by AI
Who else is applying?
What site did they apply to?
UCLA Center for Human Nutrition
What portion of applicants met pre-screening criteria?
Met criteria
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