Effects of Obesity and Intensity of Exercise on Ghrelin Levels

NCT04581980 | Completed DMC

• 2 other identifiers: 2002415R01DK129510-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating the effect of different intensities of exercise on levels of the hormone, ghrelin. In addition, we will be examining the relationship between any exercise induced changes in ghrelin and insulin sensitivity, obesity, and vascular function.

Conditions

Obesity; Insulin Resistance; Cardiovascular Risk Factor

Keywords

exercise; ghrelin; insulin resistance; vascular function; obesity; prediabetes

Outcome Measures

Primary Outcomes (1)

• Ghrelin

  We will be analyzing plasma levels of acylated and deacylated ghrelin

  Measured at 6 timepoints over 2-3 hours during each experimental visit

Secondary Outcomes (2)

• Appetite Questionnaire (VAS)

  Measured at 6 timepoints over 2-3 hours during each experimental visit

• Vascular Function (brachial flow mediated dilation)

  Measured at 5 timepoints over 2-3 hours during each experimental visit

Other Outcomes (2)

• Insulin Sensitivity

  Insulin and glucose will be collected at 5 timepoints during the OGTT, and 11 timepoints during each testing visit. The Matsuda index (mathematical model) will be used to calculate insulin sensitivity

• Body Composition

  Body composition will be measured twice during a DEXA and CT scan (takes about 30 minutes)

Study Arms (3)

Control

NO INTERVENTION

This arm will receive no exercise

Moderate Intensity Exercise

EXPERIMENTAL

This group will exercise on a cycle ergometer (Lode Bike) at moderate intensity. Moderate intensity will be defined by the lactate threshold. A heart rate monitor will be utilized at all times to record heart rate.

Other: Exercise

High Intensity Exercise

EXPERIMENTAL

This group will exercise on a cycle ergometer (Lode Bike) at high intensity. High intensity will be defined by an by 75% of the difference between the lactate threshold and peak.

Other: Exercise

Interventions

Exercise OTHER

Participants will exercise on a cycle ergometer

High Intensity Exercise; Moderate Intensity Exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• BMI between 18-40 kg/m2
• Untrained (reports less than 2 days/week of exercise)
• Weight stable (no significant loss/gain of more than 3kg in the past 3 months)
• Females must be premenopausal and report normal menstrual cycles

You may not qualify if:

• History of diabetes, gastrointestinal disease, or endocrine disorder
• Smoking (must have quit at least 6 months prior)
• Disordered eating
• Females currently pregnant or undergoing fertility treatments
• The following medications (due to their effect on insulin sensitivity ,endothelial function and/or ghrelin secretion): Synthetic growth hormone, metformin, synthetic insulin, sulfonylureas, meglitinides, Thiazolidinediones, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors , biguanides, alpha-glucosidase inhibitors, phosphodiesterase inhibitors, beta-blockers, alpha-blockers, ACE-inhibitors, ARB's, fibrates, glucocorticoids, olanzapine

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22902, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance; Motor Activity; Prediabetic State

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Arthur Weltman, Professor of Kinesiology

Model Details: Randomized, crossover design

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 9, 2020
• Study Start: October 14, 2020
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: September 17, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)