Acute Timed Exercise and 24h Metabolism

Type 2 Diabetes Clinical Trial

— TIM  

Official title:

Timed Exercise to Acutely Improve Energy and Substrate Metabolism at Night in Men and Women With Prediabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073068
• Other study ID #: NL78628.068.21
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: November 2024

Study information

• Verified date: July 2023
• Source: Maastricht University
• Contact: Marit Kotte, MSc
• Phone: 43 38 85 819
• Email: m.kotte[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Appropriate timing of lifestyle interventions may facilitate healthy rhythmicity in metabolism and optimize the effectiveness of such interventions in improving metabolic health. In this context, exercise is well-known to improve (skeletal muscle) energy metabolism and is an established intervention to improve muscle insulin sensitivity and to counter the development of type 2 diabetes (T2D). In addition, exercise may also have beneficial effects on the immune response that is known to impact on insulin sensitivity and overall metabolic health. In this study it is hypothesized that exercise performed at different times of the day exerts a differential effect on 24h metabolism in people at risk for developing T2D. To test this, a randomized controlled cross-over study is conducted in which participants are subjected to either an exercise in the morning or late afternoon while staying in the respiration chamber. Main outcome is substrate utilization during the night as measured with the respiration chamber, but 24-hrs blood draws will also be performed to examine effect of exercise on circulating metabolites.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: November 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Not meeting all inclusion criteria

• 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)

• Participation in another biomedical study within 1 month before the first study visit

• Using > 400mg caffeine daily (more than 4 cups of coffee or energy drinks)

• Smoking

• Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's opinion interfere with the study

• Antecubital veins that present tremendous difficulty in obtaining frequent blood draws (e.g. too small)

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• Timing of exercise
An acute exercise bout of cycling performed in the morning at 9 AM or at 5 PM
• Control
No exercise

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Feet sensitivity based on score on a neuropathy questionnaire		Baseline visit
Other	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
Other	Diurnal variation in core body temperature using a core temperature pill that measures 24hrs		35 hours respiration chamber stay per intervention arm
Other	Feet sensitivity based on a clinical foot assessment		Baseline visit
Primary	Nocturnal respiratory exchange ratio	Relative carbohydrate/fat oxidation during the night	35 hours respiration chamber stay per intervention arm
Secondary	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
Secondary	Immune cell phenotypes determined using blood samples obtained during the interventions		35 hours respiration chamber stay per intervention arm
Secondary	Blood glucose levels following the exercise intervention measured continuously using a continuous glucose monitor device		7 days post the exercise intervention