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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; MODY
• Intervention / Treatment: Behavioral: Physical training

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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Greenland
  • Nuuk, Greenland, 3900
    • Steno Diabetes Center Greenland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Severe heart disease

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; People with type 2 diabetes or MODY in the training group	Behavioral: Physical training; A 12 week supervised training intervention with 1 hour physical training two times a week.
Control; People with type 2 diabetes or MODY in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in BMI	BMI is measured using height and weight.	Baseline to 12 weeks
Change in fat mass	Fat mass is measured using tanita body composition analyzer.	Baseline to 12 weeks
Change in muscle mass	Muscle mass is measured using tanita body composition analyzer.	Baseline to 12 weeks
Change in bone mass	Bone mass is measured using tanita body composition analyzer.	Baseline to 12 weeks
Change in blood pressure	Blood pressure is measured with a blood pressure monitor.	Baseline to 12 weeks
Change in HbA1c	HbA1c is measured with a blood sample.	Baseline to 12 weeks
Change in HDL cholesterol	HDL cholesterol is measured with a blood sample.	Baseline to 12 weeks
Change in LDL cholesterol	LDL cholesterol is measured with a blood sample.	Baseline to 12 weeks
Change in Total cholesterol	Total cholesterol is measured with a blood sample.	Baseline to 12 weeks
Change in triglycerides	Triglycerides is measured with a blood sample.	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Greenland
• Collaborators: University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2022-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No