Exercise, Chronotype, and Prediabetes

ConditionsPrediabetes Overweight , Obesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19-75

SponsorGerman Diabetes Center

About this trial

The goal of this clinical trial is to find out whether exercising at the right time of day, based on a person's natural body clock, leads to greater health benefits in people living with prediabetes. The main question it aims to answer is whether doing a single session of exercise in the morning or in the evening affects how the body handles sugar differently in adults with prediabetes who have an extreme natural body clock. This will be done by comparing three conditions (no-exercise, morning exercise, and evening exercise) within the same participant. Each condition will be tested on a different day, with at least 14 days between the test days. During the no-exercise test days, participants will come to the study centre and will only be allowed to do sedentary activities (e.g. office work, reading, or screen time). During the morning exercise test days, participants will perform an exercise session at 9:00 am that involves short periods of very hard effort followed by short rest periods. Whereas for the evening exercise test days, the same type of exercise will be performed at 5:00 pm.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to provide signed and dated written informed consent prior to any study specific procedures

Adult men and women aged between more than 18 and ≤ 75 years

Body mass index (BMI) of 25 - 35 kg/m2

Stable weight (no weight loss or gain > 3 kg in the past 3 months)

Disqualifiers

Previously diagnosed with type 2 diabetes

Moderate to severe anemia (hemoglobin < 10 g/L)

Uncontrolled hypertension

Abnormal electrocardiogram (ECG) at rest judged by the study physician

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

28 Participants

are divided into 3 treatment groups

Group A: AM exerciseExperimental treatment 1 intervention

Group B: PM exerciseExperimental treatment 1 intervention

Group C: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

Insulin sensitivity

Effect of timed exercise on insulin sensitivity assessed using insulin sensitivity index (reported as M-value: mg x kg-1 x min-1) during an hyperinsulinemic-euglycemic clamp

Time frame