N/A
N=58
Molecular Mechanisms of Exercise Benefits to Insulin Resistant People
Insulin Resistance · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04158375 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Change in Muscle Strength — 0.37; -0.2 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resistance Exercise (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Muscle Strength |
0.37; -0.2 | — |
| PRIMARY Change in Insulin Sensitivity |
-743.7; -105.7 | — |
| PRIMARY Change in Lean Mass |
542; -377 | — |
| SECONDARY Change in Fat Percentage |
-0.89; 0.12 | — |
Summary
This proposal will investigate the underlying mechanisms of enhanced insulin sensitivity and improvement of muscle loss and performance in insulin resistant people by resistance exercise training. Based on the investigator's preliminary data, they hypothesize that the key regulators of health benefits of resistance training are two genes: PGC-1a4 and PPARB;, and that the increased expression of these genes following resistance training facilitates storage of glucose in muscle and enhances its utilization for the energy need of muscle for contraction as well as enhancing muscle mass and performance. The investigators will also determine whether resistance training can reduce the higher oxidative stress in insulin resistant humans and improve their muscle protein quality.
Eligibility Criteria
Inclusion criteria
- age 50-75yrs
- BMI 30-38kg/m2
- hip to waist ratio of >0.85 in women and 1.0 in men
- fasting glucose ≥100-140mg/dl
Lean Group
- age 50-75 years
- hip to waist ratio of 2 days per week
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- Inpatient psychiatric treatment in the past 6 months
- Presence of a known adrenal disorder
- Abnormal liver function test results (Transaminase >2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
- Abnormal renal function test results (calculated GFR 10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise
- Abuse of alcohol or recreational drugs
- Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
- Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg) at the time of screening.
- Oral steroids
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
- Restrictions on Use of Other Drugs or Treatments:
- Medications that may impact study end points such as mitochondrial biology eg. beta blockers
- Anti-hyperglycemic drugs including metformin
- Any other medication that the investigator believes is a contraindication to the subject's participation.
Data sourced from ClinicalTrials.gov (NCT04158375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.