Effect of Circadian Rhythm and Physical Exercise in Overweight Type 1 Diabetes Patients
Primary Purpose
Type 1 Diabetes, Overweight
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
High intensity interval training (HIIT)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring high intensity interval training, metabolomics
Eligibility Criteria
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 exclusion criteria for diabetes subjects:
- diabetes duration less than 6 months,
- proliferative or severe non-proliferative retinopathy,
- chronic kidney disease with glomerular filtration rate (GFR) <60 ml/min,
Sites / Locations
- Ersta sjukhusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Type 1 diabetes with overweight
Overweight but otherwise healthy control subjects
Arm Description
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), a single bout, randomly performed either in the morning or in the afternoon in a cross-over design.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 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.
Full Information
NCT ID
NCT05277532
First Posted
February 18, 2022
Last Updated
April 19, 2023
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT05277532
Brief Title
Effect of Circadian Rhythm and Physical Exercise in Overweight Type 1 Diabetes Patients
Official Title
Elucidating the Interplay Between Circadian Rhythm and Physical Exercise on Metabolism in Patients With Type 1 Diabetes and Overweight
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Overweight
Keywords
high intensity interval training, metabolomics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A randomized crossover design (comparing morning vs afternoon exercise) in parallel groups (Type 1 diabetes and control subjects)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Type 1 diabetes with overweight
Arm Type
Active Comparator
Arm Description
High intensity interval training (HIIT), a single bout, randomly performed either in the morning or in the afternoon in a cross-over design.
Arm Title
Overweight but otherwise healthy control subjects
Arm Type
Active Comparator
Arm Description
High intensity interval training (HIIT), a single bout, randomly performed either in the morning or in the afternoon in a cross-over design.
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval training (HIIT)
Intervention Description
HIIT performed either in the morning or in the afternoon
Primary Outcome Measure Information:
Title
Time in Glucose target range (4-10 mmol/L) for tissue glucose from CGM.
Description
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
Secondary Outcome Measure Information:
Title
Tissue specific effects of HIIT in type 1 diabetes vs healthy subjects
Description
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.
Title
Time below Glucose target range (< 4 mmol/L) for tissue glucose from CGM.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 exclusion criteria for diabetes subjects:
diabetes duration less than 6 months,
proliferative or severe non-proliferative retinopathy,
chronic kidney disease with glomerular filtration rate (GFR) <60 ml/min,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Toft, Assoc Prof
Phone
+46 706722363
Email
eva.toft@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Qvisth, M.D.
Phone
+46 87146500
Ext
6630
Email
veronica.qvist@erstadiakoni.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid Dahlman, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ersta sjukhus
City
Stockholm
ZIP/Postal Code
11691
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Toft, Assoc Prof
Phone
+4687146500
Ext
6245
Email
eva.toft@ki.se
First Name & Middle Initial & Last Name & Degree
Veronica Qvist, MD, Ph D
Phone
+4687146500
Ext
6630
Email
veronica.qvist@erstadiakoni.se
First Name & Middle Initial & Last Name & Degree
Ingrid Dahlman, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Circadian Rhythm and Physical Exercise in Overweight Type 1 Diabetes Patients
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