An interventional study of High intensity interval training (HIIT) in Type 1 Diabetes and Overweight, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
Cardiometabolic risk in patients with abdominal obesity and type 1 diabetes can be moderated by life style modifications. There is an intimate link between gene regulation and circadian rhythm in mediating response to exercise in a variety of insulin sensitive organs.
The aim of this project is to evaluate, by intervention, the interplay of circadian rhythm and high intensity interval training (HIIT) on glucose control and skeletal muscle metabolism in patients with overweight with or without type 1 diabetes (T1D).
High intensity interval training (HIIT) is a promising intervention for lifestyle treatment in type 1 diabetes. In spite of the interplay between circadian rhythms and exercise, the time of day in which the most robust adaption to HIIT can be achieved is unknown. The main goal of the study is to compare the efficacy of morning and afternoon HIIT in regulating blood glucose values in participants with type 1 diabetes and overweigt and to compare the effect in overweight but otherwise healthy subjects. Additionally, the investigators aim to to elucidate the metabolomics in the different settings. Healthy controls will be used to compare whether the effect of HIIT and interplay with circadian rhythm on organ metabolism is impaired in patients with T1D.
A randomized cross-over trial with 25 participants with type 1 diabetes and 25 control subjects will be performed. The participants will be examined on three occasions on an out-patient basis . Visit 1 aim to run baseline measurements and a bicycle test to define maximum exertion . On visit 2 the participants will perform a single bout of HIIT (6 1-minute pulses at maximal exertion, interspersed with 1-minute recovery) either in the morning (09.00) or afternoon (16.00). After a 1-week washout period, the participants will return for visit 3 and an opposing exercise time. Primarily, the efficacy of the morning and afternoon HIIT will be judged by the continuous glucose monitor (CGM) -based glycaemia measurements. Additionally, during the visits the investigators will collect repeated blood samples to assess the effect of exercise timing on the diurnal hormonal rhythms. Muscle biopsies will be collected before and directly after HIIT.
The hypothesis is that afternoon HIIT will be more efficacious in controlling blood glucose based on the preliminary data gathered from a 'free living' pilot study in type 2 diabetes. The current study will aim to compare the morning and afternoon exercise in controlled conditions, eliminating the effects of dietary intake, medication and sleep cycle disruption. Additionally, the tissue factors responsible for the differing glycaemic response to morning and afternoon exercise will be elucidated.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
Additional exclusion criteria for diabetes subjects:
High intensity interval training (HIIT), a single bout, randomly performed either in the morning or in the afternoon in a cross-over design.
Behavioral: High intensity interval training (HIIT)
High intensity interval training (HIIT), a single bout, randomly performed either in the morning or in the afternoon in a cross-over design.
Behavioral: High intensity interval training (HIIT)
HIIT performed either in the morning or in the afternoon
Time in Glucose target range (4-10 mmol/L) for tissue glucose from CGM.
Time in target glucose range (expressed as % of total time) measured by continuous subcutaneous glucose sensors following morning or afternoon HIIT respectively. Measurements are uploaded from the CGM device and analyzed.
Time frame: 48 hours
Tissue specific effects of HIIT in type 1 diabetes vs healthy subjects
Plasma and skeletal muscle samples will be subjected to transcriptomic and/or metabolomic analyses to evaluate the impact of HIIT on metabolic outcomes.
Time frame: 2 hours; muscle and blood samples are collected directly before and after HIIT, respectively.
Time below Glucose target range (< 4 mmol/L) for tissue glucose from CGM.
Time in the hypoglycaemic range (expressed as % of total time) measured by continuous subcutaneous glucose sensors following morning or afternoon HIIT respectively. Measurements are uploaded from the CGM device and analyzed.
Time frame: 48 hours
Plan to share: No
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Karolinska Institutet