Lifestyle therapy for Frailty

Michael E. DeBakey VA Medical Center, Houston, TX, Houston, TX
Frailty+14 More ConditionsLifestyle therapy - Behavioral
65 - 85
All Sexes

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).

Eligible Conditions
  • Frailty
  • Frailty Syndrome
  • Geriatric Frailty Syndrome
  • Preoperative Frailty
  • Sarcopenic Obesity
  • Aging
  • Frailty in Aging
  • Debilitated States

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 46 Secondary · Reporting Duration: 6 months

6 months
Chang in body fat
Change in Cognitive composite scores
Change in Impact of Weight on Quality of Life_Lite (IWQOL-lite) score
Change in Medical Outcomes 36-Item short form Health survey (SF-36)
Change in Tumor necrosis factor
Change in blood pressure
Change in bone microarchitecture
Change in bone strength
Change in dynamic balance
Change in fasting serum glucose
Change in fasting serum insulin
Change in fiber cross sectional area
Change in fiber type-specific response
Change in gait speed
Change in gene expression of senescence associated secretory phenotype
Change in habitual physical activity assessed by questionnaires
Change in habitual physical activity measured objectively
Change in high-sensitivity c-reactive protein
Change in hip, lumbar spine, and wrist bone mineral density (BMD)
Change in insulin growth factor 1
Change in lean body mass
Change in mood
Change in muscle quality
Change in muscle strength
Change in p16
Change in p21
Change in peak aerobic power
Change in protein expression of senescence associated secretory phenotype
Change in satellite cells
Change in serum 25-OH vitamin D
Change in serum C-telopeptide
Change in serum Interleukin 6
Change in serum adiponectin
Change in serum leptin
Change in serum lipids
Change in serum osteocalcin
Change in serum parathyroid hormone
Change in serum procollagen type 1 N propeptide
Change in serum sclerostin
Change in static balance
Change in subjective ability to function
Change in telomere length in skeletal muscles and whole blood
Change in the modified Physical Performance Test (PPT)
Change in thigh fat
Change in thigh muscle
Change in wrist and tibial cortical and trabecular BMD
Changed in concentration of targeted metabolites

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Side Effects for

Standard Care
8%Moderate renal dysfunction defined as GFR 30-60 ml/min/1.73m2
4%Other infections
1%Genitourinary infection
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT02561130) in the Standard Care ARM group. Side effects include: Moderate renal dysfunction defined as GFR 30-60 ml/min/1.73m2 with 8%, Other infections with 4%, Genitourinary infection with 1%.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

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

Lifestyle Therapy plus MetforminExperimental Group · 2 Interventions: Lifestyle therapy, Metformin Hydrochloride · Intervention Types: Behavioral, Drug
Healthy lifestyle plus MetforminActiveComparator Group · 2 Interventions: Metformin Hydrochloride, Healthy Lifesylte · Intervention Types: Drug, Behavioral
Lifestyle Therapy plus PlaceboPlaceboComparator Group · 2 Interventions: Lifestyle therapy, Placebo · Intervention Types: Behavioral, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle therapy
Completed Phase 4
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Baylor College of MedicineOTHER
946 Previous Clinical Trials
5,980,187 Total Patients Enrolled
2 Trials studying Frailty
100 Patients Enrolled for Frailty
VA Office of Research and DevelopmentLead Sponsor
1,517 Previous Clinical Trials
2,731,123 Total Patients Enrolled
8 Trials studying Frailty
30,504 Patients Enrolled for Frailty
Michael E. DeBakey VA Medical CenterFED
62 Previous Clinical Trials
15,394 Total Patients Enrolled
2 Trials studying Frailty
600 Patients Enrolled for Frailty
Dennis T Villareal, MDPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX
10 Previous Clinical Trials
576 Total Patients Enrolled
2 Trials studying Frailty
28 Patients Enrolled for Frailty

Eligibility Criteria

Age 65 - 85 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not been regularly exercising for at least 6 months, with less than 1 hour per week or less than 2 times per week.

Who else is applying?

What state do they live in?
What site did they apply to?
Michael E. DeBakey VA Medical Center, Houston, TX100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria33.3%
Met criteria66.7%
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?
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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.