Acute Timed Exercise and 24h Metabolism

NCT05073068 | Completed DMC

• 1 other identifier: NL78628.068.21
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this randomized controlled cross-over study is to investigate if an acute, glycogen lowering exercise bout performed either in the morning or late afternoon differentially affects the respiratory exchange ratio at night in men and women with prediabetes. For this purpose, participants will stay in a respiration chamber and will be subjected to either an exercise bout in the morning or late afternoon.

Conditions

Type 2 Diabetes; Overweight and Obesity

Keywords

Day-night rhythm; Metabolism; Metabolic flexibility; Exercise; Glycogen

Outcome Measures

Primary Outcomes (1)

• Nocturnal respiratory exchange ratio

  Relative carbohydrate/fat oxidation during the night

  35 hours respiration chamber stay per intervention arm

Secondary Outcomes (3)

• 24 hour energy and substrate metabolism determined using oxygen and carbondioxide levels as measured with whole-chamber respirometry

  35 hours respiration chamber stay per intervention arm

• Immune cell phenotypes determined using blood samples obtained during the interventions

  35 hours respiration chamber stay per intervention arm

• Blood glucose levels following the exercise intervention measured continuously using a continuous glucose monitor device

  7 days post the exercise intervention

Other Outcomes (5)

• Diurnal variation in circulating glucoregulatory hormones (e.g. insulin) analysed in blood samples obtained throughout the day

  35 hours respiration chamber stay per intervention arm

• Feet sensitivity based on score on a neuropathy questionnaire

  Baseline visit

• Diurnal variation in metabolite levels (e.g. glucose, free fatty acids) analysed in blood samples obtained throughout the day

  35 hours respiration chamber stay per intervention arm

Study Arms (3)

AM exercise

EXPERIMENTAL

Behavioral: Timing of exercise

PM exercise

EXPERIMENTAL

Behavioral: Timing of exercise

Control

ACTIVE COMPARATOR

Behavioral: Control

Interventions

Timing of exercise BEHAVIORAL

An acute exercise bout of cycling performed in the morning at 9 AM or at 5 PM

AM exercise; PM exercise

Control BEHAVIORAL

No exercise

Control

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Healthy (determined by dependent physician)
• Man or post-menopausal woman
• Age between 50 - 75 years
• BMI ≥ 25 kg/m2
• Pre-diabetes based on meeting at least one of the following criteria: impaired glucose tolerance defined as plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during oral glucose tolerance test in screening, impaired fasting glucose defined as fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l, insulin resistance defined as a glucose clearance rate ≤ 360 mL/kg/min as determined using OGIS120, HbA1c of 5.7-6.4%
• Regular sleeping habits (7 - 9h of daily sleep)
• Stable diet and weight: No weight gain or loss \> 3kg in the last three months

You may not qualify if:

• Fasting plasma glucose
• ≥ 7.0 mmol/L
• Hemoglobin \< 7.8 mmol/L
• Previously diagnosed with type 2 diabetes
• Uncontrolled hypertension
• In case of an abnormal electrocardiogram at rest: this will be discussed with the responsible medical doctor
• Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed
• Any contra-indication to the Equivital telemetric pill
• Hypomotility disorders of the gastro-intestinal tract
• Extreme early bird or extreme night person (score ≤30 or ≥70 on morning-eveningness questionnaire self assessment)
• Heavily varying sleep-wake rhythm
• Night shift work during last 3 months
• Travel across \> 1 time zone in the last 3 months
• Frequent engagement in programmed exercise as judged by the investigator
• Significant food allergies/intolerance (seriously hampering study meals)

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Joris Hoeks, Dr

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will receive a code so that the person in charge with the data quality check and the data analyses will be blinded to the interventions.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: October 11, 2021
• Study Start: March 16, 2022
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: June 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)