Effect of Circadian Rhythm and Physical Exercise in Overweight Type 1 Diabetes Patients
NCT ID: NCT05277532
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2022-05-18
2026-10-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Type 1 diabetes with overweight
High intensity interval training (HIIT), a single bout, randomly performed either in the morning or in the afternoon in a cross-over design.
High intensity interval training (HIIT)
HIIT performed either in the morning or in the afternoon
Overweight but otherwise healthy control subjects
High intensity interval training (HIIT), a single bout, randomly performed either in the morning or in the afternoon in a cross-over design.
High intensity interval training (HIIT)
HIIT performed either in the morning or in the afternoon
Interventions
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High intensity interval training (HIIT)
HIIT performed either in the morning or in the afternoon
Eligibility Criteria
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Inclusion Criteria
* type 1 diabetes or healthy subjects
Exclusion Criteria
* cardiovascular disease (CVD),
* blood pressure \>160/95,
* pregnancy,
* treatment with other pharmaceutical drugs than insulin, stable dose of thyroid hormone, statins, and antihypertensive drugs (excluding beta blockers).
* diabetes duration less than 6 months,
* proliferative or severe non-proliferative retinopathy,
* chronic kidney disease with glomerular filtration rate (GFR) \<60 ml/min,
18 Years
50 Years
ALL
Yes
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Eva Toft
Associate Professor
Principal Investigators
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Ingrid Dahlman, Professor
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Ersta sjukhus
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EPN 2021-05137
Identifier Type: -
Identifier Source: org_study_id
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