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The Effect of Sitting and Moderate Exercise on Plasma Insulin and Glucose Responses to an Oral Glucose Tolerance Test

Primary Purpose

Sedentary Behavior, Insulin Sensitivity, Sedentary Lifestyle

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SIT
ACTIVE
EX
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sedentary Behavior focused on measuring glucose tolerance, exercise, insulin sensitivity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy, untrained/recreationally active men and women.
  • Women must not be pregnant or post-menopausal.

Exclusion Criteria:

  • Heart problems or coronary artery disease
  • Hypertension
  • Lung or respiratory problems
  • Chest pain, fainting, or heart palpitations during exercise, or told to give up sports because of health problems.

Sites / Locations

  • University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SIT

SIT+EX

ACTIVE+EX

Arm Description

Subject will be asked to take <3,000 steps for two intervention days prior to an oral glucose tolerance test on the third day.

Subject will be asked to take <3,000 steps for two intervention days. On the evening of the second intervention day, the subject will cycle for one hour at 65% of VO2peak. The subject will undergo an oral glucose tolerance test on the morning of the third day.

Subject will be asked to take >10,000 steps for two intervention days. On the evening of the second intervention day, the subject will cycle for one hour at 65% of VO2peak. The subject will undergo an oral glucose tolerance test on the morning of the third day.

Outcomes

Primary Outcome Measures

Insulin sensitivity
The investigators will measure glucose and insulin levels from data collected during the oral glucose tolerance test.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2019
Last Updated
December 9, 2019
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT04195165
Brief Title
The Effect of Sitting and Moderate Exercise on Plasma Insulin and Glucose Responses to an Oral Glucose Tolerance Test
Official Title
The Effect of Sitting and Moderate Exercise on Plasma Insulin and Glucose Responses to an Oral Glucose Tolerance Test
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
September 23, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesize that cycling for 1 hour of exercise at 65% peak oxygen consumption (VO2peak) after sitting >13 hr/day (SIT+EX) will not be different in postprandial plasma insulin responses compared to the control of only sitting (SIT). Furthermore, the investigators hypothesize that the SIT and SIT+EX groups will have a less favorble insulin response compared to the physically active group after performing the same 1-hour exercise bout (ACTIVE+EX).
Detailed Description
Twelve healthy, untrained male and female participants will complete three different trials in a randomized, crossover design, each occurring over 4 days with a 3-4 day interval between the trials. Each trial consists of 3 phases. The first two days will serve as a control phase (C1) that will allow for familiarization, followed by a 2-day intervention phase consisting of 2 days of sitting 13 h/d for both groups (D1- D2) (SIT+EX and ACTIVE+EX). On the evening of Day 2 the SIT+EX and ACTIVE+EX groups will cycle for 1 hour at 65% of VO2peak. On the morning of Day 3 participants in all conditions will ingest a drink containing 75-g of glucose and undergo a two-hour oral glucose tolerance test (OGTT). For all trials, participants will refrain from any exercise other than that described for the study. One week prior to the initiation of the first trial, participants will visit the Human Performance Laboratory (HPL) for a 10 min exercise test to measure peak oxygen uptake while cycling (VO2peak). On the same day, participants will be instrumented with an activity monitor worn on their thigh to record time sitting, standing and lying as well as step count (activPal). During the two control day (C1), participants will be asked to refrain from any planned exercise but will be asked to walk or move between 6,000 - 7,500 steps per day, which is considered to be 'low level of physical activity'(31). During the intervention days (D1-D2), those completing SIT and SIT+EX conditions will be asked to remain seated throughout much of the day and achieve <3,000 steps, while those completing the ACTIVE+EX condition will be asked to break up their sitting with low-intensity physical activity, not exercise, and achieve >10,000 steps. However, the only difference between trials is that at 18:00 h during SIT+EX and ACTIVE+EX they will cycle for 1-hr at 65% VO2peak. On the day of the OGTT (D3), participants will report to the laboratory at 07:00 h. Body weight will be measured. They will lay down for 5 minutes and a catheter will be inserted into an antecubital vein and a fasting blood sample will then be collected 10 min before consumption of high-glucose drink (75 g) composed of water and glucose monohydrate. Approximately 5 ml of blood will be collected at 10, 20, 30, 60, 90 and 120 min after ingestion. Approximately 60 ml of blood will be sampled during each of the three trials and thus the total will amount to approximately 180 ml (6 ounces, 12 tablespoons). This amounts to approximately 2-4% of a person's total blood volume. All blood samples collected will be transferred to K2 EDTA collection tubes, centrifuged at 2,000 g for 15 minutes at 4◦C and then stored in -80◦C freezer until later analysis. During OGTT, participants will sit quietly reading, watching movies, and/or surfing the Internet. Participants will also be asked to keep a consistent sleep/wake cycle during the trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Behavior, Insulin Sensitivity, Sedentary Lifestyle
Keywords
glucose tolerance, exercise, insulin sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SIT
Arm Type
Experimental
Arm Description
Subject will be asked to take <3,000 steps for two intervention days prior to an oral glucose tolerance test on the third day.
Arm Title
SIT+EX
Arm Type
Experimental
Arm Description
Subject will be asked to take <3,000 steps for two intervention days. On the evening of the second intervention day, the subject will cycle for one hour at 65% of VO2peak. The subject will undergo an oral glucose tolerance test on the morning of the third day.
Arm Title
ACTIVE+EX
Arm Type
Experimental
Arm Description
Subject will be asked to take >10,000 steps for two intervention days. On the evening of the second intervention day, the subject will cycle for one hour at 65% of VO2peak. The subject will undergo an oral glucose tolerance test on the morning of the third day.
Intervention Type
Behavioral
Intervention Name(s)
SIT
Intervention Description
For the SIT and SIT+EX conditions, the subject will be asked to take <3,000 steps. This is meant to achieve ~12-13 hours of sitting per day, are the investigators are measuring the effect of inactivity and exercise on insulin sensitivity.
Intervention Type
Behavioral
Intervention Name(s)
ACTIVE
Intervention Description
For the ACTIVE+EX condition, the subject will be asked to take >10,000 steps for the two intervention days. This is meant to simulate an active lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
EX
Other Intervention Name(s)
Exercise
Intervention Description
The SIT+EX and ACTIVE+EX conditions will include an exercise bout on the evening of the second intervention day, and have the oral glucose tolerance test the next morning.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
The investigators will measure glucose and insulin levels from data collected during the oral glucose tolerance test.
Time Frame
Up to 4 weeks after data completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy, untrained/recreationally active men and women. Women must not be pregnant or post-menopausal. Exclusion Criteria: Heart problems or coronary artery disease Hypertension Lung or respiratory problems Chest pain, fainting, or heart palpitations during exercise, or told to give up sports because of health problems.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael B Dial
Phone
8018915699
Email
Michael.dial@utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Dial
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael B Dial
Phone
801-891-5699
Email
michael.dial@utexas.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Sitting and Moderate Exercise on Plasma Insulin and Glucose Responses to an Oral Glucose Tolerance Test

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