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Effect of Circadian Rhythm and Physical Exercise in Overweight Type 1 Diabetes Patients

Elucidating the Interplay Between Circadian Rhythm and Physical Exercise on Metabolism in Patients With Type 1 Diabetes and Overweight

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05277532
Enrollment
50
Registered
2022-03-14
Start date
2022-05-18
Completion date
2026-10-31
Last updated
2024-10-15

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

Conditions

Overweight, Type 1 Diabetes

Keywords

high intensity interval training, metabolomics

Brief summary

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).

Detailed description

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.

Interventions

BEHAVIORALHigh intensity interval training (HIIT)

HIIT performed either in the morning or in the afternoon

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A randomized crossover design (comparing morning vs afternoon exercise) in parallel groups (Type 1 diabetes and control subjects)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI 25-30 * type 1 diabetes or healthy subjects

Exclusion criteria

* nicotine usage, * 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). Additional

Design outcomes

Primary

MeasureTime frameDescription
Time in Glucose target range (4-10 mmol/L) for tissue glucose from CGM.48 hoursTime 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.

Secondary

MeasureTime frameDescription
Tissue specific effects of HIIT in type 1 diabetes vs healthy subjects2 hours; muscle and blood samples are collected directly before and after HIIT, respectively.Plasma and skeletal muscle samples will be subjected to transcriptomic and/or metabolomic analyses to evaluate the impact of HIIT on metabolic outcomes.
Time below Glucose target range (< 4 mmol/L) for tissue glucose from CGM.48 hoursTime 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.

Countries

Sweden

Contacts

Primary ContactEva Toft, Assoc Prof
eva.toft@ki.se+46 706722363
Backup ContactVeronica Qvisth, M.D.
veronica.qvist@erstadiakoni.se+46 87146500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026