The main objective of this study is to determine whether prolonged exercise training in the afternoon (15:00-17:00 PM) differs from exercise training in the morning (07:00-09:00 AM) in improving nocturnal glucose levels in individuals with pre-…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is the nocturnal glucose levels measured by a
continuous glucose monitor (CGM).
Secondary outcome
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.
Background summary
Various metabolic processes, including resting metabolic rate, insulin
sensitivity and insulin secretion, follow a recurring 24-hour cycle. These
rhythms are shown to be disturbed in in pre-diabetes volunteers compared to
young healthy volunteers. In a retrospective analysis of an exercise training
program performed either in the morning or afternoon, we found that the
afternoon training group improved their peripheral insulin sensitivity and
fasting plasma glucose levels to a greater extent than the morning group.
However, underlying mechanisms are unclear.
Study objective
The main objective of this study is to determine whether prolonged exercise
training in the afternoon (15:00-17:00 PM) differs from exercise training in
the morning (07:00-09:00 AM) in improving nocturnal glucose levels in
individuals with pre-diabetes, and to investigate its underlying mechanisms.
Study design
The present study is a randomized double arm longitudinal intervention study in
a pre and post design.
Intervention
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 or afternoon training
time. To assess the outcomes, participants will come to the university for a
35,5h measurement period both before and after the 12-week training program.
Study burden and risks
Before starting the exercise training, participants will visit the University 3
times for a screening and two pre-intervention visits including a 35,5h stay at
the research unit. During the exercise intervention period, subjects will visit
the University 3 times per week for 12 consecutive weeks to receive supervised
exercise training. After 12 weeks of exercise training, participants will again
stay at the research unit for 35,5h and measurements will be repeated. The main
burden of this study is the large time investment for the exercise training
period (12 weeks, 3 times/week). Moreover, the pre- and post-training test days
comprise several non-invasive and invasive measurements. The used techniques
are safe, but the muscle biopsies can cause some discomfort and may result in a
local bruise or hematoma. Likewise, blood sampling can cause a local hematoma.
The risk of infection and/or prolonged bleeding is very low due to
state-of-the-art techniques and sterility measures. In total, we will draw
approximately 271 ml blood during the entire study period. Measurements
performed during the time course of the study can potentially lead to
unexpected medical findings. Participants and their GP will be informed about
such a finding. If a participant does not want to be informed about incidental
findings, participation in this study is not possible.
Universiteitssingel 50
Maastricht 6200 MD
NL
Universiteitssingel 50
Maastricht 6200 MD
NL
Listed location countries
Age
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 <=
11.1 mmol/l 120 minutes after glucose drink consumption during OGTT in screening
o Impaired Fasting Glucose (IFG): Fasting plasma glucose >= 6.1 mmol/l and <= 6.9
mmol/l
o Insulin Resistance: glucose clearance rate <= 360 mL/kg/min, as determined
during the OGTT using OGIS120
o HbA1c of 5.7-6.4%
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 <8.0 mmol/L, Women: Hb <7.0 mmol/l
• Heavily varying sleep-wake rhythm (i.e. night shift work and travels across
time zones).
• Significant food allergies/intolerance (seriously hampering study meals)
• Blood donation during or within 2 months prior to the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | n.n.b. |
| CCMO | NL83421.068.22 |