A Feasibility Study of a 12 Week Training Intervention With Patients With Type 2 Diabetes and MODY in Greenland
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Steno Diabetes Center Greenland
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Adherence
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The goal of this study is to investigate to what extent a 12-week training course for people with type 2 diabetes mellitus (T2DM) or MODY can be conducted in a clinical context with clinically relevant improvements in cardiometabolic risk factors and quality of life?
The main questions it aims to answer are:
- To investigate the feasibility of supervised training for people with T2DM or MODY in a clinical context in Greenland.
- To investigate evidence of the effect of combined aerobic and strength training on cardiometabolic risk factors and mental well-being.
- To investigate the signs of efficacy and different interactions with the type of disease.
Detailed Description
Globally, type 2 diabetes mellitus (T2DM) is a major public health issue. This is also the fact in Greenland, the biggest island in the world. Twice as many Greenlanders as Danes have diabetes, and this is due to both lifestyle and genes. It is estimated that 7% of T2DM patients in Greenland have Maturity Onset Diabetes of the Young (MODY), which is hereditary and rare elsewhere. Exercise improves blood sugar control in T2DM, reduces cardiovascular risk factors such as hypertension and dyslipidemia, contributes to weight loss and improves fitness and well-being. Less is known of how people with MODY responds to exercise. Today, the Greenlandic health care system only offers supervised physical training to people with osteoarthritis in two towns in Greenland, but in the future, they would like to offer supervised physical training to people with other conditions too. Relevance: As mentioned above, this study aims to evaluate the feasibility of a 12-week supervised physical training intervention for people with T2DM or MODY and to investigate signs of efficacy and different interactions with the type of disease.
Investigators
Maja Hykkelbjerg Nielsen
MSc in Public Health, PhD student
Steno Diabetes Center Greenland
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes or MODY
- •Living in the capital in Greenland, Nuuk
Exclusion Criteria
- •Severe heart disease
Outcomes
Primary Outcomes
Adherence
Time Frame: Baseline to 12 weeks
Adherence is in this study the proportion of completed training sessions (n=0-24 training sessions). The number of completed training sessions was registered by the physiotherapists.
Secondary Outcomes
- Change in HDL cholesterol(Baseline to 12 weeks)
- Change in BMI(Baseline to 12 weeks)
- Change in LDL cholesterol(Baseline to 12 weeks)
- Change in fat mass(Baseline to 12 weeks)
- Change in muscle mass(Baseline to 12 weeks)
- Change in quality of life(Baseline to 12 weeks)
- Change in bone mass(Baseline to 12 weeks)
- Change in Total cholesterol(Baseline to 12 weeks)
- Change in triglycerides(Baseline to 12 weeks)
- Change in blood pressure(Baseline to 12 weeks)
- Change in HbA1c(Baseline to 12 weeks)