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Lifestyle Changes + Metformin for Frailty in Obese Seniors (DEMFOS Trial)

Phase 3
Recruiting
Led By Dennis T Villareal, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

DEMFOS Trial 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).

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if combining lifestyle therapy (diet and exercise) with metformin is more effective than diet and exercise alone in reversing frailty due to obesity in older adults. Participants will be randomly assigned to receive either the drug plus lifestyle changes or a placebo alongside the same lifestyle interventions.See study design
What are the potential side effects?
Metformin may cause digestive issues like diarrhea or nausea; it can also lead to vitamin B12 deficiency over time. Lifestyle changes might result in muscle soreness from new exercises and potential nutritional deficiencies if not monitored properly.

DEMFOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the modified Physical Performance Test (PPT)
Secondary outcome measures
Chang in body fat
Change in Cognitive composite scores
Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score
+34 more

Side effects data

From 2018 Phase 4 trial • 154 Patients • NCT02561130
5%
Genitourinary infection
4%
Abdominal pain
4%
Injury
3%
Abscess drainage
1%
Moderate renal dysfunction defined as GFR 30-60 ml/min/1.73m2
1%
Viral gastroenteritis
1%
Resection of liver metastases from colorectal cancer
1%
Cholecystitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intervention
Standard Care

DEMFOS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Lifestyle Therapy plus MetforminExperimental Treatment2 Interventions
Diet-induced weight loss and Exercise Training plus Metformin 1500 mg daily
Group II: Healthy lifestyle plus MetforminActive Control2 Interventions
Healthy lifestyle and Metformin 1500 mg daily
Group III: Lifestyle Therapy plus PlaceboPlacebo Group2 Interventions
Diet-induced weight loss and Exercise Training plus Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle therapy
2015
Completed Phase 4
~320
Metformin Hydrochloride
2016
Completed Phase 4
~1460

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,319 Total Patients Enrolled
9 Trials studying Frailty
30,750 Patients Enrolled for Frailty
Michael E. DeBakey VA Medical CenterFED
64 Previous Clinical Trials
15,674 Total Patients Enrolled
2 Trials studying Frailty
600 Patients Enrolled for Frailty
Baylor College of MedicineOTHER
1,001 Previous Clinical Trials
6,002,138 Total Patients Enrolled
2 Trials studying Frailty
100 Patients Enrolled for Frailty

Media Library

Frailty Research Study Groups: Lifestyle Therapy plus Metformin, Lifestyle Therapy plus Placebo, Healthy lifestyle plus Metformin
Frailty Clinical Trial 2023: Lifestyle therapy Highlights & Side Effects. Trial Name: NCT04221750 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
What site did they apply to?
Michael E. DeBakey VA Medical Center, Houston, TX
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

I am prepared to lose weight. Because I have a problem with being obesity and I want something to help me loose weight.
PatientReceived no prior treatments
I have tried several drugs that do not work and I am looking for help with reducing obesity.
PatientReceived no prior treatments
I have tired so many other drugs and it does not work and I looked into this one and it looks interesting.
PatientReceived 2+ prior treatments
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.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long does screening take? The possible negative effect, if any, and is a placebo effect part of this study?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Michael E. DeBakey VA Medical Center, Houston, TX: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors
2021. "Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04221750.
~37 spots leftby Sep 2025
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