Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02701751
Other study ID # HUM00102522
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date October 24, 2016

Study information

Verified date March 2022
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to examine the effects of chronic exercise training and an acute session of exercise on key risk factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and blood pressure) and alterations in subcutaneous adipose tissue structure and metabolic function in overweight adults.


Description:

Subjects will be asked to complete the Substrate Metabolism Laboratory General Screening Questionnaire and American Heart Association Health/Fitness Questionnaire to determine if they are eligible to complete the preliminary testing procedures. If eligible, subjects will be asked to visit the Substrate Metabolism Laboratory to participate in the preliminary testing procedures (listed below) before participating in the experimental trial. PRELIMINARY TESTING PROCEDURES: - Blood pressure, height and weight measurements - Body Composition Assessment (~20 min) - Exercise Fitness Test (~10 min) - Resting Metabolic Rate (RMR) measurement (~30 min) - 3 hour Oral Glucose Tolerance Test (OGTT) EXPERIMENTAL TRIAL: The evening before the experimental trial, subjects will eat a standardized dinner meal and snack. The meal and snack must be eaten at specific times as indicated by the research staff. After eating the snack, subjects will need to fast (no food or beverages - besides water) overnight. Participants who exercise regularly will be instructed to exercise exactly 3 days before the experimental trial, and then abstain from their exercise training program until after the study is complete. In the morning, subjects will return to the Substrate Metabolism Laboratory. The research team will collect a blood sample from the subject's hand or forearm and a small sample of fat tissue in the subject's abdomen with a needle. Next, subjects will exercise on a treadmill at a moderate intensity for about 1 hour. Immediately after exercising the research team will collect a second blood sample. Subjects will remain in the laboratory for 1 hour after exercising, and then the research team will collect another blood and fat tissue sample. Upon completion of the experimental trial, subjects will be provided a snack before leaving the laboratory.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 24, 2016
Est. primary completion date October 24, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Age: 18-40 - Body Mass Index: 25-35 kg/m2 - Regular exercisers: (=4 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities) - Non-exercisers: no regularly planned exercise/physical activity - Women must have regularly occurring menses and must be premenopausal Exclusion Criteria: - Blood pressure > 140/90 mm Hg - Pregnant or lactating - Evidence/history of cardiovascular or metabolic disease - Medications known to affect lipid or glucose metabolism

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise session
A blood sample and fat biopsy will be obtained before and after the 60 minute moderate exercise session. There is no drug or device intervention in this study.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PPARg mRNA expression The study team will quantify the abundance of key adipogenic markers in adipose tissue biopsy samples change from baseline at 1 hour post exercise
Primary Cytokine abundance in adipose tissue The study team will measure cytokine proteins in adipose tissue change from baseline at 1 hour post exercise
Secondary Total Cholesterol Plasma concentrations of total- cholesterol will be measured. change from baseline at 1 hour post exercise
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1