Clinical trial NCT05747118: A Feasibility Study of a 12 Week Training Intervention With Patients With Type 2 Diabetes and MODY in Greenland
Official title: A Feasibility Study of a 12 Week Training Intervention With Patients With Type 2 Diabetes and MODY in Greenland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
MODY
Lead sponsor: Steno Diabetes Center Greenland
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2023-02-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants were recruited within the Capital of Greenland, Nuuk. Males and females \>18 years old and diagnosed with T2DM or MODY were included. The exclusion criteria were severe heart disease.

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:

1. To investigate the feasibility of supervised training for people with T2DM or MODY in a clinical context in Greenland.
2. To investigate evidence of the effect of combined aerobic and strength training on cardiometabolic risk factors and mental well-being.
3. 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.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes or MODY
* Living in the capital in Greenland, Nuuk

Exclusion Criteria:

* Severe heart disease

Primary outcomes:
measure: Adherence
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in quality of life
timeFrame: Baseline to 12 weeks
measure: Change in BMI
timeFrame: Baseline to 12 weeks
measure: Change in fat mass
timeFrame: Baseline to 12 weeks
measure: Change in muscle mass
timeFrame: Baseline to 12 weeks
measure: Change in bone mass
timeFrame: Baseline to 12 weeks
measure: Change in blood pressure
timeFrame: Baseline to 12 weeks
measure: Change in HbA1c
timeFrame: Baseline to 12 weeks
measure: Change in HDL cholesterol
timeFrame: Baseline to 12 weeks
measure: Change in LDL cholesterol
timeFrame: Baseline to 12 weeks
measure: Change in Total cholesterol
timeFrame: Baseline to 12 weeks
measure: Change in triglycerides
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Nuuk
country: Greenland
facility: Steno Diabetes Center Greenland
Study officials:
References: