Status:
COMPLETED
Exercise Volume and Beta-cell Function in T2D The DOSE-EX Randomized Trial
Lead Sponsor:
Mathias Ried-Larsen
Conditions:
Type 2 Diabetes Mellitus
Type2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This project will provide an exercise-based lifestyle intervention with the potential to reduce complications for patients with short standing type 2 diabetes (T2D). While exercise is widely accepted ...
Detailed Description
A 4-armed, 16-week, parallel-group, assessor-blinded, randomized, clinical trial. Participants will be randomly allocated (1:1:1:1), stratified by sex Interventions: The lifestyle interventions will...
Eligibility Criteria
Inclusion
- Diagnosed with diabetes type 2 and/or HbA1c ≥ 48 mmol/mol if no treatment with anti-diabetic medication and/or use of antidiabetic medication
- Caucasian
- No diagnose of Type 1 diabetes, mature onset diabetes of the young, Latent autoimmune diabetes of adults
- T2D 0-6 years of duration
- No treatment with insulin
- Body Mass Index (BMI) \>27 kg/m2 and \<40 kg/m2
- No known or signs of intermediate or severe microvascular complications to diabetes (retino-, neuro- or nephropathy)
- No known cancer
- No Known lung disease
- No known cardiovascular disease
- No known thyroid disease
- No known liver disease
- No known autoimmune disease
- No other endocrine disorder causing obesity
- No current treatment with anti-obesity medication
- No current treatment with anti-inflammatory medication
- No weight loss of \> 5kg within the last 6 months
- No diagnose of depression or treatment with anti-depressive medication, ongoing or within the last three months before enrolment
- No diagnose of psychiatric disorder or treatment with anti-psychotic medication
- No history of suicidal behavior or ideations within the last three months before enrolment
- No previous surgical treatment for obesity (excluding liposuction \> 1 year prior to enrolment)
- Not pregnant/considering pregnancy
- No functional impairments that prevents the performance of intensive exercise
- Accept of medical regulation by the U-TURN endocrinologist
- Inactivity, defined as \< 1,5 hours of structured physical activity pr. week at moderate intensity and cycling \< 30 minutes/5 km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)
- No participation in other research intervention studies
Exclusion
- HbA1c: \>=75 mmol/mol with no glucose lowering medications
- HbA1c: \>=64 mmol/mol with mono glucose lowering therapy (if compliant with the prescription)
- HbA1c: \>=57 mmol/mol with \>=dual glucose lowering therapy (if compliant with the prescription)
- estimated glomerular filtration rate\<60 mL/min
- Protein or glucose in the urine at pre-screening
- No biochemical sign of other major diseases
- Presence of circulating glutamate-decarboxylase anti body (GAD) 65
- Objective findings that contraindicates participation in intensive exercise
- Anamnestic findings that contraindicates participation in the study
- Unable to allocate the needed time to fulfill the intervention
- Language barrier, mental incapacity, unwillingness or inability to understand and be able to complete the interventions
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2021
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03769883
Start Date
December 12 2018
End Date
October 28 2021
Last Update
May 10 2024
Active Locations (1)
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1
Center for Physical Activity Research, Copenhagen University Hospital
Copenhagen, Denmark, 2100