Study Summary
This trial will test whether a weight-loss and exercise program, plus the drug metformin, can help obese older adults who are also losing muscle mass and strength (a condition called sarcopenic obesity).
- Frailty
- Frailty Syndrome
- Geriatric Frailty Syndrome
- Preoperative Frailty
- Sarcopenic Obesity
- Aging
- Frailty in Aging
- Debilitated States
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 46 Secondary · Reporting Duration: 6 months
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
3 Treatment Groups
Healthy lifestyle plus Metformin
1 of 3
Lifestyle Therapy plus Metformin
1 of 3
Lifestyle Therapy plus Placebo
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group
114 Total Participants · 3 Treatment Groups
Primary Treatment: Lifestyle therapy · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 65 - 85 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 75.0% |
| California | 25.0% |
What site did they apply to?
| Michael E. DeBakey VA Medical Center, Houston, TX | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 33.3% |
| Met criteria | 66.7% |
Why did patients apply to this trial?
- "Because I have a problem with being obesity and I want something to help me loose weight"
- "I have tried several drugs that do not work and I am looking for help with reducing obesity."
- "Looking for a study that will produce a longtime effect in the area of weight loss and change in behavioral health/therapy/nutrition that can be maintained producing a more active lifestyle."
How many prior treatments have patients received?
| 0 | 66.7% |
| 3+ | 33.3% |
What questions have other patients asked about this trial?
- "The possible negative effect, if any, and is a placebo effect part of this study?"
Frequently Asked Questions
What sort of health conditions can Lifestyle therapy help ameliorate?
"Many times, doctors will recommend lifestyle changes, or 'lifestyle therapy,' as a method to help patients suffering from exercise. However, this type of treatment is also effective for other conditions, such as type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome." - Anonymous Online Contributor
Can people who are twenty-one and older participate in this research project?
"This trial's age range for participants is from 65 years old to 85 years old." - Anonymous Online Contributor
What is the risk profile for individuals who undergo Lifestyle therapy?
"Lifestyle therapy received a score of 3 because, although it is only in Phase 3, there is some data supporting efficacy as well as multiple rounds of data supporting safety." - Anonymous Online Contributor
Are there any prerequisites for participating in this research?
"Up to 114 elderly patients that suffer from frailty may be enrolled in this study. Admission requirements include being between 65-85 years old as well as meeting the following conditions: having a stable body weight for the last 6 months (no more than 2 kg above or below their current weight), a BMI of 30 kg/m2 or greater, and being sedentary (regularly exercising less than 1 hour per week or 2 times per week for the past 6 months)." - Anonymous Online Contributor
What other investigations have included Lifestyle therapy in their methodology?
"As of now, there are one hundred and eighty clinical trials underway that focus on lifestyle therapy. Out of those, forty-six are in Phase 3. Even though the majority of these studies on lifestyle therapy originate from Pittsburgh, Pennsylvania, there are one thousand six hundred and seventy-seven locations conducting these trials." - Anonymous Online Contributor