NCT06820658

Brief Summary

The objective of the study is to use neurological techniques to obtain quantitative measurements of nervous system control of skeletal muscle activity in adults aged 60-85 who are either long-term resistance exercisers or who are untrained.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
29mo left

Started Feb 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Feb 2025Oct 2028

First Submitted

Initial submission to the registry

January 21, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

February 26, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

3.5 years

First QC Date

January 21, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

neuromusculartranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • Electromyography (EMG) response following Transcranial Magnetic Stimulation (TMS)

    To assess connectivity between the nervous system and skeletal muscle, we will use transcranial magnetic stimulation (TMS) coupled with electromyography (EMG). TMS uses a magnetic field to carry a short-lasting electrical current pulse into the brain where it stimulates neurons, particularly in superficial regions of cerebral cortex, and neural activities can be measured at different levels along the motor pathways (predominantly the CST). When combined with EMG, this approach will allow us to quantify changes in muscular activity after stimulating the CST and other descending tracts and to assess the neuromuscular connectivity. EMG assess the health of muscles and the nerve cells that control them (motor neurons). EMG results can reveal nerve dysfunction, muscle dysfunction or problems with nerve-to-muscle signal transmission. Motor neurons transmit electrical signals that cause muscles to contract. Electrodes will then translate signals into graphs, sounds or numerical values.

    21 days

Study Arms (2)

Highly resistance-trained

Diagnostic Test: Neuromuscular TestDiagnostic Test: DEXADiagnostic Test: Mixed Meal Tolerance TestDiagnostic Test: Strength Test

Untrained

Diagnostic Test: Neuromuscular TestDiagnostic Test: DEXADiagnostic Test: Mixed Meal Tolerance TestDiagnostic Test: Strength Test

Interventions

Neuromuscular TestDIAGNOSTIC_TEST

To measure neuromuscular connectivity, Transcranial Magnetic Stimulation (TMS) will be used to stimulate regions of the cerebral cortex known to control specific muscles. Electromyography (EMG) activity will then be measured from the following muscle groups: deltoid, biceps, extensor digitorum communis, abductor pollicis brevis, abductor digiti minimi, and first dorsal interosseous muscle.

Highly resistance-trainedUntrained
DEXADIAGNOSTIC_TEST

The DEXA test uses X-rays to measure how many grams of calcium and other bone minerals are packed into a segment of bone. The test also measures the amount of fat-free mass, and fat mass.

Highly resistance-trainedUntrained

Fasting blood will be collected for glucose, insulin, and c-peptide. Participants will be provided with a milkshake with a fixed amount of protein, carbohydrates, and fat. Glucose, insulin, and c-peptide will be measured at multiple time points (every 10 minutes) until four hours after consumption (50% Fat, 30% Carbohydrate HO, 20% Protein). Approximately 70mls of blood will be drawn during this time

Highly resistance-trainedUntrained
Strength TestDIAGNOSTIC_TEST

Knee extensor strength will be tested by gradually increasing the workload on a pneumatic Keiser knee extension machine. The test will begin with a warm-up of 4-5 reps with one leg at 30-50 psi. Then the participant will increase the workload at self-selected intervals ranging from 5-20psi until a maximum effort is achieved. If a rep is failed, then the workload will be reduced by 5psi until a successful rep is performed or a workload is reached in which a successful rep had been previously achieved. Handgrip strength will be tested using a handheld dynamometer (Baseline® standard hydraulic hand dynamometer). The test is performed with the participant seated with the elbow unsupported and flexed at 90 degrees, forearm neutral, wrist held between 0-15 degrees of ulnar deviation (Horowitz, 1997). Maximum grip is the average of three 3-5 second trials.

Highly resistance-trainedUntrained

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 80 participants will be equally divided into resistance-trained and untrained groups. Participants will be matched for age, sex, and BMI. Participants are to have a fasting blood sugar under 140 mg/dL. Untrained men and women will have a hip to waist ratio of \>0.85 in women or \>80cm and \>0.90 in men or \>94cm. Participants will be from the Rochester Minnesota area aged 60-85 with a BMI 30-38.

You may qualify if:

  • Participant must have a BMI between 18.5 and 38
  • Participant be aged between 60 and 85
  • Regularly exercises at least 5 days a week a minimum of 30 minutes per day.
  • Engages in less than 2 days of exercise less than 30 minutes each day.
  • Participant must use the Mayo Clinic patient online portal.
  • Participant must be able to understand English without the need of an interpreter.
  • Must be willing to be contacted for research
  • Participant must be willing and capable to provide consent.
  • Participants shall be generally healthy as deemed acceptable by the principal investigator
  • Men and women will be participant in this study. Women cannot be pregnant during this study.

You may not qualify if:

  • Surgical History - Gastric surgery, pacemaker placement, weight loss surgery, metabolic and obstetric surgery.
  • Smokers will be excluded from the study.
  • Medications: Insulins, common diabetic drugs, anti-hyperglycemic drugs, beta blockers cardiac selective, beta-blockers noncardiac selective, oral steroids, opioids anti-depressants, and hormones
  • Conidiations and Diagnosis: Disorder of coronary artery, hepatic failure, gastroparesis, disorder of the adrenal gland, drug related disorders, substance abuse, malignant neoplastic disease, psychotic disorders, disorder of skeletal muscle, finding of brain, chronic kidney disease, renal failure syndrome, disorder of pulmonary circulation, cerebrovascular disease, neuro developmental disorder, disorder of immune function, disorder of central nervous system.
  • Participants are not to have an abnormal value as part of a lipid panel within the past 6 months.
  • Participant will be excluded if they have recreational drug use or a history of alcohol abuse
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
  • Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
  • Participant will be excluded if they have epilepsy.
  • Participant will be excluded if they have cranial metal/device implants
  • Participant will be excluded if they are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • K. S. Nair, M.D., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2025

First Posted

February 11, 2025

Study Start

February 26, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

July 30, 2025

Record last verified: 2025-07

Locations