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

NCT05277532 | Recruiting

• 1 other identifier: EPN 2021-05137
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes; Overweight

Keywords

high intensity interval training; metabolomics

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours

Secondary Outcomes (2)

• Tissue specific effects of HIIT in type 1 diabetes vs healthy subjects

  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.

  48 hours

Study Arms (2)

Type 1 diabetes with overweight

ACTIVE COMPARATOR

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)

Overweight but otherwise healthy control subjects

ACTIVE COMPARATOR

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)

Interventions

High intensity interval training (HIIT) BEHAVIORAL

HIIT performed either in the morning or in the afternoon

Overweight but otherwise healthy control subjects; Type 1 diabetes with overweight

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).
• diabetes duration less than 6 months,
• proliferative or severe non-proliferative retinopathy,
• chronic kidney disease with glomerular filtration rate (GFR) \<60 ml/min,

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Ersta sjukhus

Stockholm, 11691, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Overweight

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ingrid Dahlman, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Toft, Assoc Prof

CONTACT

+46 706722363; eva.toft@ki.se

Veronica Qvisth, M.D.

CONTACT

+46 87146500; veronica.qvist@erstadiakoni.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 14, 2022
• Study Start: May 18, 2022
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)