Timing exercise training as strategy to improve nocturnal glucose levels and substrate metabolism in men and woman with pre-diabetes

Timing exercise training as strategy to improve nocturnal glucose levels and substrate metabolism in men and woman with pre-diabetes - Timed Training Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53883

Enrollment

100

Registered

2023-06-12

Start date

2023-12-20

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glucose intolerance insulin resistance

Interventions

Participants will perform a 12-weeks supervised high intensity interval training (HIIT) program with three ~30 min exercise sessions per week. Participants will be randomly assigned to the morning o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Participants are able to provide signed and dated written informed consent prior to any study specific procedures • Aged 40-75 years • Body mass index (BMI) >=25 kg/m2 • Male, or postmenopausal (at least 1 year post cessation of menses) female • Have suitable veins for cannulation or repeated venepuncture • Pre-diabetes based on one or a combination of the following criteria: o Impaired Glucose Tolerance (IGT): plasma glucose values >= 7.8 mmol/l and = 6.1 mmol/l and

Exclusion criteria

Exclusion criteria: • Type 2 diabetes • Patients with active congestive heart failure and and/or severe renal and or liver insufficiency • Uncontrolled hypertension • Any contra-indication for MRI scanning • Alcohol consumption of >3 servings per day for man and >2 serving per day for woman • Smoking • Unstable body weight (weight gain or loss > 5kg in the last 3 months) • Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator which would possibly hamper our study results • Medication use known to hamper subject*s safety during the study procedures • Subjects who do not want to be informed about unexpected medical findings • Men: Hb

Design outcomes

Primary

Measure	Time frame
The primary study endpoint is the nocturnal glucose levels measured by a continuous glucose monitor (CGM).	—

Secondary

Measure	Time frame
The secondary outcomes are 24h energy and substrate metabolism. Exploratory outcomes are body composition, intrahepatic lipid content, hepatic insulin sensitivity, hepatic glycogen levels, maximal aerobic capacity, skeletal muscle oxidative capacity, visceral and subcutaneous adipose tissue volume, sleeping metabolic rate, blood glucose levels (continuously measured over 7days), feet sensitivity, immune responses and patient perceived experiences with timed exercise.	—

Measure

Time frame

The secondary outcomes are 24h energy and substrate metabolism. Exploratory outcomes are body composition, intrahepatic lipid content, hepatic insulin sensitivity, hepatic glycogen levels, maximal aerobic capacity, skeletal muscle oxidative capacity, visceral and subcutaneous adipose tissue volume, sleeping metabolic rate, blood glucose levels (continuously measured over 7days), feet sensitivity, immune responses and patient perceived experiences with timed exercise.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)