Lifestyle Changes + Metformin for Frailty in Obese Seniors
(DEMFOS Trial)
Trial Summary
What is the purpose of this trial?
The continuing increase in prevalence of obesity in older adults including many older Veterans has become a major health concern. The clinical trial will test the central hypothesis that a multicomponent intervention consisting of lifestyle therapy (diet-induced weight loss and exercise training) plus metformin will be the most effective strategy for reversing sarcopenic obesity and frailty in older Veterans with obesity.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking metformin, any other glucose-lowering drugs, or bone-acting drugs like estrogen or bisphosphonates.
Will I have to stop taking my current medications?
The trial requires that participants do not take metformin or any other glucose-lowering drugs. If you are currently taking these medications, you would need to stop before joining the trial.
What data supports the idea that Lifestyle Changes + Metformin for Frailty in Obese Seniors is an effective treatment?
The available research shows that combining lifestyle changes with metformin can be effective for frailty in obese seniors. One study found that exposure to metformin was linked to a lower risk of frailty in older adults with diabetes, suggesting that metformin helps reduce frailty. Another study showed that a lifestyle intervention promoting weight loss and physical activity led to a lower prevalence of frailty compared to a control group. These findings suggest that the combination of lifestyle changes and metformin can help manage frailty in obese seniors.12345
What data supports the effectiveness of the treatment Lifestyle Changes + Metformin for Frailty in Obese Seniors?
Research shows that metformin, a drug commonly used for type 2 diabetes, is associated with a lower risk of frailty in older adults. Additionally, intensive lifestyle interventions that promote weight loss and physical activity have been shown to reduce frailty in older adults with obesity and diabetes.12345
What safety data exists for using lifestyle changes and metformin in treating frailty in obese seniors?
The research indicates that metformin is associated with a lower risk of frailty in older adults with type 2 diabetes, as shown in a study of veterans. Metformin is generally safe but can cause gastrointestinal side effects and is not recommended for patients with renal insufficiency or severe liver disease. Lifestyle interventions, while beneficial for metabolic control, have not shown significant changes in glycemic control or quality of life in some studies. Further research is needed to confirm the effectiveness and safety of combining lifestyle changes with metformin for frailty in obese seniors.13678
Is the combination of lifestyle changes and metformin safe for obese seniors?
Is the drug Metformin a promising treatment for frailty in obese seniors?
How does the treatment of lifestyle changes and Metformin differ from other treatments for frailty in obese seniors?
This treatment is unique because it combines lifestyle changes, like diet and exercise, with Metformin, a drug that may lower the risk of frailty by targeting shared mechanisms between frailty and type 2 diabetes. This dual approach addresses both weight management and metabolic health, which are crucial for improving frailty in obese seniors.123910
Research Team
Dennis T Villareal, MD
Principal Investigator
Michael E. DeBakey VA Medical Center, Houston, TX
Eligibility Criteria
This trial is for sedentary obese seniors with a BMI of 30 or higher who've maintained a stable weight recently and are willing to consent. It's not for those on glucose-lowering drugs, with severe cardiopulmonary disease, renal impairment, uncontrolled hypertension, recent cancer (except skin), using bone drugs, osteoporosis sufferers, diabetics, terminal illness patients or those with conditions that limit exercise/diet/metformin use.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lifestyle therapy (diet-induced weight loss and exercise training) plus metformin or placebo for six months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lifestyle therapy
- Metformin Hydrochloride
Lifestyle therapy is already approved in United States, European Union for the following indications:
- Childhood obesity
- Weight management
- Childhood obesity
- Weight management
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Michael E. DeBakey VA Medical Center
Collaborator
Baylor College of Medicine
Collaborator