A Feasibility Study of a 12 Week Training Intervention With Patients With Type 2 Diabetes and MODY in Greenland
1 other identifier
observational
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFirst Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
February 28, 2023
CompletedApril 12, 2023
April 1, 2023
5 months
February 7, 2023
April 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Change in quality of life
Baseline to 12 weeks
Change in BMI
Baseline to 12 weeks
Change in fat mass
Baseline to 12 weeks
Change in muscle mass
Baseline to 12 weeks
Change in bone mass
Baseline to 12 weeks
- +6 more secondary outcomes
Study Arms (2)
Intervention
People with type 2 diabetes or MODY in the training group
Control
People with type 2 diabetes or MODY in the control group
Interventions
A 12 week supervised training intervention with 1 hour physical training two times a week.
Eligibility Criteria
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.
You may qualify if:
- Type 2 diabetes or MODY
- Living in the capital in Greenland, Nuuk
You may not qualify if:
- Severe heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Steno Diabetes Center Greenlandlead
- University of Southern Denmarkcollaborator
Study Sites (1)
Steno Diabetes Center Greenland
Nuuk, 3900, Greenland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc in Public Health, PhD student
Study Record Dates
First Submitted
February 7, 2023
First Posted
February 28, 2023
Study Start
August 15, 2022
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 12, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share