Short, Simple, Exercise to Improve Circadian Dependent Postprandial Glycemic Responses

Sponsor

San Diego State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05783752

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Postprandial Glycemic Response Postprandial Hyperglycemia Postprandial Insulin	Behavioral: Stair Stepping Behavioral: No exercise control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effects of Stair Stepping on Late Day Postprandial Glycemia

Actual Study Start Date :

Feb 20, 2023

Anticipated Primary Completion Date :

Feb 19, 2024

Anticipated Study Completion Date :

Feb 19, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stair-Stepping then Control 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.	Behavioral: Stair Stepping 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 Behavioral: No exercise control Participants avoid exercise within 1 hour of eating a meal
Experimental: Control then Stair-Stepping 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.	Behavioral: Stair Stepping 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 Behavioral: No exercise control Participants avoid exercise within 1 hour of eating a meal

Arm

Intervention/Treatment

Experimental: Stair-Stepping then Control

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.

Behavioral: Stair Stepping

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

Behavioral: No exercise control

Participants avoid exercise within 1 hour of eating a meal

Experimental: Control then Stair-Stepping

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.

Behavioral: Stair Stepping

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

Behavioral: No exercise control

Participants avoid exercise within 1 hour of eating a meal

Outcome Measures

Primary Outcome Measures

Postprandial Blood Glucose [continuous measure from meal consumption up to 1 hour post meal]
mg/dL

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Diego State University	San Diego	California	United States	92182

Sponsors and Collaborators

San Diego State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jochen Kressler, Associate Professor, San Diego State University

ClinicalTrials.gov Identifier:

NCT05783752

Other Study ID Numbers:

HS-2023-0003

First Posted:

Mar 24, 2023

Last Update Posted:

Mar 24, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperglycemia

Study Results

No Results Posted as of Mar 24, 2023