NCT05073068Completed
Acute Timed Exercise and 24h Metabolism
Timed Exercise to Acutely Improve Energy and Substrate Metabolism at Night in Men and Women With Prediabetes
Source: ClinicalTrials.gov · Last updated 13 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 25 Aug 2021
- Start date
- 16 Mar 2022
- Primary completion date
- 21 Nov 2024
- Lead sponsor
- Maastricht University
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05073068
What you commit to
- Study type: Interventional
- Participants enrolled: 35
- From 16 Mar 2022 to the primary completion date, 21 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed with type 2 diabetes
- Participation in another biomedical study within 1 month before the first study visit
Other illness
- Uncontrolled hypertension
- Hypomotility disorders of the gastro-intestinal tract
- Significant food allergies/intolerance (seriously hampering study meals)
- Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's opinion interfere with the study
Lab values
- Fasting plasma glucose
- ≥ 7.0 mmol/L
- Hemoglobin \< 7.8 mmol/L
Other
- Not meeting all inclusion criteria
- 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
- 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
- Using \> 400mg caffeine daily (more than 4 cups of coffee or energy drinks)
- Smoking
- Antecubital veins that present tremendous difficulty in obtaining frequent blood draws (e.g. too small)
Who the study is looking for
- 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
Age in the registry: 50 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.