Night Time Walking to Improve Glycaemic Control in Healthy Adults

NCT04958317 | Withdrawn DMC

• 1 other identifier: Night Glucose response-walk
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomised crossover trial to compare early vs late walking on postprandial glycaemic response at night time.

Conditions

Postprandial Hyperglycemia; Insulin Resistance

Keywords

glucose tolerance; meal timing; insulin; postprandial; walking

Outcome Measures

Primary Outcomes (1)

• Postprandial glucose

  Change in glucose incremental area under the curve (iAUC) in response to a meal challenge

  Three hour glucose iAUC will be calculated at nine time points (0, 15, 30, 45, 60, 90, 120, 150 and 180 mins) after beginning consumption of the test meal.

Secondary Outcomes (1)

• Postprandial insulin

  Three hour insulin iAUC will be calculated at six time points (0, 30, 60, 90, 120 and 180 mins) after beginning consumption of the test meal.

Study Arms (2)

Early exercise

PLACEBO COMPARATOR

Participants will exercise for 30 minutes prior to an evening meal

Other: Early exercise

Late exercise

EXPERIMENTAL

Participants will exercise for 30 minutes after an evening meal

Other: Late exercise

Interventions

Early exercise OTHER

Participants will exercise for 30 minutes prior to an evening meal.

Early exercise

Late exercise OTHER

Participants will exercise for 30 minutes after an evening meal.

Late exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women aged 18 to 65 years of age
• Waist circumference of \<94cm and \<80cm for Caucasian males and females, respectively
• Waist circumference of \<90cm and \<80 cm for Asian males and females, respectively
• Willingness to provide written informed consent and willingness to participate and comply with the study

You may not qualify if:

• Current or recent treatment (within 6 months) with medications that influence blood glucose
• Fasting blood glucose ≥ 7 mmol/L
• Individuals diagnosed with type 1 or type 2 diabetes mellitus, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac) or any other condition deemed unstable
• Serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery
• Not able to walk for 30 mins at 5-5.5 km/hr
• Women planning pregnancy, pregnant or lactating.

Sponsors & Collaborators

• Monash University: lead

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: This is a single masking study.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 12, 2021
• Study Start: December 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share