A Feasibility Study of a 12 Week Training Intervention With Patients With Type 2 Diabetes and MODY in Greenland

Type 2 Diabetes Clinical Trial

Official title:

A Feasibility Study of a 12 Week Training Intervention With Patients With Type 2 Diabetes and MODY in Greenland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747118
• Other study ID #: 2022-21
• Status: Completed
• Start date: August 15, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Steno Diabetes Center Greenland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Severe heart disease

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• MODY
• Type 2 Diabetes

Intervention

Behavioral:
• Physical training
A 12 week supervised training intervention with 1 hour physical training two times a week.

Locations

Country	Name	City	State
Greenland	Steno Diabetes Center Greenland	Nuuk

Sponsors (2)

Lead Sponsor	Collaborator
Steno Diabetes Center Greenland	University of Southern Denmark

Country where clinical trial is conducted

Greenland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	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.	Baseline to 12 weeks
Secondary	Change in quality of life	Quality of life is estimated using 12-Item Short Form Survey (SF-12). In the short form SF-12, physical (SF12-PCS) and mental (SF12-MCS) component summary scores are calculated as sub-dimensions. The total score of the physical and mental component summary of the scale varies between 0-100. An increase in the score indicates well-being, and a decrease indicates a state of disability.	Baseline to 12 weeks
Secondary	Change in BMI	BMI is measured using height and weight.	Baseline to 12 weeks
Secondary	Change in fat mass	Fat mass is measured using tanita body composition analyzer.	Baseline to 12 weeks
Secondary	Change in muscle mass	Muscle mass is measured using tanita body composition analyzer.	Baseline to 12 weeks
Secondary	Change in bone mass	Bone mass is measured using tanita body composition analyzer.	Baseline to 12 weeks
Secondary	Change in blood pressure	Blood pressure is measured with a blood pressure monitor.	Baseline to 12 weeks
Secondary	Change in HbA1c	HbA1c is measured with a blood sample.	Baseline to 12 weeks
Secondary	Change in HDL cholesterol	HDL cholesterol is measured with a blood sample.	Baseline to 12 weeks
Secondary	Change in LDL cholesterol	LDL cholesterol is measured with a blood sample.	Baseline to 12 weeks
Secondary	Change in Total cholesterol	Total cholesterol is measured with a blood sample.	Baseline to 12 weeks
Secondary	Change in triglycerides	Triglycerides is measured with a blood sample.	Baseline to 12 weeks