Effects of Exercise and Energy Balance on 24-hour Blood Glucose Control

NCT03350997 | Completed

• 1 other identifier: HUM00120520
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The study team will assess "free-living" 24h glucose control using continuous glucose monitors (CGM) over an 88h period on two separate occasions. Importantly, standardized meals will be provided and will be consumed at specific times each day of the CGM measurement period. These meals will be identical on day 1 and day 3 of measurement. Each subject will complete two CGM periods, which will be identical except for the calorie and macronutrient content of the post-exercise dinner. In addition, during trial 1, two CGM's will be worn, while only 1 CGM will be worn on trial 2.

Conditions

Metabolic Disease; Adipose Tissue

Keywords

Exercise

Outcome Measures

Primary Outcomes (2)

• Average Post-prandial glucose values

  Average Post-prandial glucose values (1 hour, 2 hour, and 3 hours) will be measured

  1 week

• area under curve Post-prandial glucose values (1 hour, 2 hour, and 3 hours)

  1 hour, 2 hour, and 3 hours time-point for Post-prandial glucose values will be measured

  1 week

Secondary Outcomes (3)

• 24 hour glycemic response

  1 day

• Area under curve - 24 hour glycemic response

  1 day

• CGM Sensor Variability when measured simultaneously

  1 week

Study Arms (2)

Trial 1

EXPERIMENTAL

Subjects will have two CGM devices placed on either side of the abdomen, near the belly button. Trial 1 Exercise - subjects will use a mouthpiece and nose clip (which will allow all of their expired air to pass through the metabolic cart for analysis of oxygen consumption and carbon dioxide production) for \~5 min at the beginning, middle and toward the end of exercise to verify they are exercising at 65% of VO2peak. This will allow us to accurately measure energy expenditure (kcal) during exercise. One hour after the exercise session, participants will eat a standardized dinner which includes the energy expended from their exercise session (+ 350 kcal).

Behavioral: Trial 1 Exercise

Trial 2

EXPERIMENTAL

Subjects will have one CGM device placed on one side of the abdomen. Trial 2 Exercise - subjects will exercise at 65% of VO2peak. One hour after the exercise session, participants will eat a standardized dinner which will NOT include the energy expended from their exercise session (- 350 kcal).

Behavioral: Trial 2 Exercise

Interventions

Trial 2 Exercise BEHAVIORAL

During the exercise session, subjects will exercise at 65% of VO2peak. One hour after the exercise session, participants will eat a standardized dinner which will NOT include the energy expended from their exercise session (- 350 kcal).

Trial 2

Trial 1 Exercise BEHAVIORAL

During the exercise session, subjects will use a mouthpiece and nose clip (which will allow all of their expired air to pass through the metabolic cart for analysis of oxygen consumption and carbon dioxide production) for \~5 min at the beginning, middle and toward the end of exercise to verify they are exercising at 65% of VO2peak. This will allow us to accurately measure energy expenditure (kcal) during exercise. One hour after the exercise session, participants will eat a standardized dinner which includes the energy expended from their exercise session (+ 350 kcal).

Trial 1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-40
• Body Mass Index: 20-30 kg/m2

You may not qualify if:

• Pregnant or lactating
• Evidence/history of cardiovascular or metabolic disease
• Medications known to affect glucose metabolism

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Metabolic Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Behavior

Study Officials

• Jeffrey F Horowitz

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Movement Science, School of Kinesiology

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 22, 2017
• Study Start: October 21, 2016
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)