Short, Simple, Exercise to Improve Circadian Dependent Postprandial Glycemic Responses
Primary Purpose
Postprandial Glycemic Response, Postprandial Hyperglycemia, Postprandial Insulin
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stair Stepping
No exercise control
Sponsored by
About this trial
This is an interventional prevention trial for Postprandial Glycemic Response
Eligibility Criteria
Inclusion Criteria: between 18 and 65 years able to climb and descend stairs access to stairs Exclusion Criteria: glycemic medications that vary in dosage dosage from meal to meal or day to day (eg insulin titrated to meal size or carbohydrate content)
Sites / Locations
- San Diego State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Stair-Stepping then Control
Control then Stair-Stepping
Arm Description
Participants start with stair-stepping 15 minutes after meals on day 1 followed by no exercise on day 2. Sequence continues throughout the 10 days.
Participants start with no exercise on day 1 followed by stair-stepping 15 minutes after meals on day 2. Sequence continues throughout the 10 days.
Outcomes
Primary Outcome Measures
Postprandial Blood Glucose
mg/dL
Secondary Outcome Measures
Full Information
NCT ID
NCT05783752
First Posted
March 13, 2023
Last Updated
March 13, 2023
Sponsor
San Diego State University
1. Study Identification
Unique Protocol Identification Number
NCT05783752
Brief Title
Short, Simple, Exercise to Improve Circadian Dependent Postprandial Glycemic Responses
Official Title
Effects of Stair Stepping on Late Day Postprandial Glycemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
February 19, 2024 (Anticipated)
Study Completion Date
February 19, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical trial is to test whether one minute of stair stepping at a comfortable pace can reduce blood sugar after meals. The main objectives of the study are:
Compare continuously measured post-meal glucose after stair-stepping to control condition Compare continuously measured post-meal glucose after stair-stepping between meals Assess interaction between condition and meal to determine if the effect of stair-stepping on post-meal glucose depends on meal
Participants will be in the study for 10 days and will be asked to:
Wear a continuous glucose monitor over the course of the study Perform either one minute of comfortable pace stair stepping 15 min after each meal OR no exercise 1 hour after eating a meal on alternating days Perform a dietary recall every two days Perform no exercise within one hour after each meal on any day during the study Consume no calories within one hour after each meal during the study
Detailed Description
After being informed about the study and potential risks, all participants giving written informed consent will undergo a screening to determine eligibility for study entry. At day 1, patients who meet the eligibility requirements will be randomly assigned to Arm 1(stair stepping day followed by no exercise day sequence) or Arm 2(no exercise day followed by stair stepping day sequence). At this time participants will also be familiarized with the continuous glucose (i.e., blood sugar) monitor they will wear for ten days, be instructed how to fill out a food log every day and determine a comfortable stair stepping pace. On day 10 participants will return to the lab for sensor removal and transmitter return.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Glycemic Response, Postprandial Hyperglycemia, Postprandial Insulin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stair-Stepping then Control
Arm Type
Experimental
Arm Description
Participants start with stair-stepping 15 minutes after meals on day 1 followed by no exercise on day 2. Sequence continues throughout the 10 days.
Arm Title
Control then Stair-Stepping
Arm Type
Experimental
Arm Description
Participants start with no exercise on day 1 followed by stair-stepping 15 minutes after meals on day 2. Sequence continues throughout the 10 days.
Intervention Type
Behavioral
Intervention Name(s)
Stair Stepping
Intervention Description
1 minute of stair-stepping (30 seconds up, 30 seconds down) at a self-selected pace identified on day 0 starting 15 minutes after each meal
Intervention Type
Behavioral
Intervention Name(s)
No exercise control
Intervention Description
Participants avoid exercise within 1 hour of eating a meal
Primary Outcome Measure Information:
Title
Postprandial Blood Glucose
Description
mg/dL
Time Frame
continuous measure from meal consumption up to 1 hour post meal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
between 18 and 65 years
able to climb and descend stairs
access to stairs
Exclusion Criteria:
glycemic medications that vary in dosage
dosage from meal to meal or day to day (eg insulin titrated to meal size or carbohydrate content)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jochen Kressler, PhD
Phone
(619) 594-0323
Email
jkressler@sdsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Moore, MS
Email
jmoore3@sdsu.edu
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92182
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short, Simple, Exercise to Improve Circadian Dependent Postprandial Glycemic Responses
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