Life Without Diabetes
Study Details
Study Description
Brief Summary
The aim of the study 'Live - without diabetes' is to investigate the effects of increased physical activity on a daily basis with or without (high intense interval training) HIIT (short and intense: 3 minutes per week) during 12 weeks in risk individuals with pre-diabetes
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A total of 125 individuals with pre-diabetes will be included and randomized into four different groups (N=25, each group): 1) Increased daily activity detected by the pedometer, 2) increased daily activity detected by the pedometer + HIIT, 3) HIIT, and 4) increased daily activity detected by the pedometer + group intervention 5) a control group (maintain unchanged activity and life-style during the duration of the study).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High intense interval training (HIIT) 3 x 20 sec, 3 x week |
Behavioral: High intense interval training
|
| Experimental: Increased daily activity detected by the pedometer 10.000 steps a day |
Behavioral: Increased daily activity detected by the pedometer
|
| Experimental: Increased daily activity detected by te pedometer+HIIT 10.000 steps + 3 x 20 sec, 3 x week |
Behavioral: Increased daily activity detected by the pedometer+HIIT
|
| Experimental: Increased daily activity (pedometer)+group intervention 10.000 steps + group intervention |
Behavioral: Increased daily activity detected by the pedometer+group intervention
|
| No Intervention: Control group
|
Outcome Measures
Primary Outcome Measures
- Changes in insulin sensitivity [At baseline and after 12 weeks]
The primary endpoint is insulin sensitivity, and it will be assessed by changes in the area under the curve from baseline to end-of-study assessed by the Cederholm Index and Matsuda Index
Secondary Outcome Measures
- Changes in oxygen peak oxygen uptake [At baseline and after 12 weeks]
Assessed from a physical fitness test (VO2peak)
- Changes in glycaemic control [At baseline and after 12 weeks]
Measured as fasting plasma glucose, HbA1c
- Changes in key proteins in glucose and fat metabolism (Skeletal muscle) [At baseline and after 12 weeks]
Expression/content of key proteins in skeletal muscle tissure (AU units)
- Changes in body weight (kg) [At baseline and after 12 weeks]
Measured by Dual-energy X-ray Absorptiometry, DXA
- Changes in key proteins in glucose and fat metabolism (Adipose fat tissure) [At baseline and after 12 weeks]
Expression/content of key proteins in adipose tissue (AU units)
- Patient-reported outcome measure [At baseline and after 12 weeks]
Health related quality of life measured from Short Form 36 (SF36). Where scores are presented as norm-based scores (0-100) with higher scores indicating better perceived health status.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Body mass index (BMI) > 25 kg/m2
-
Prediabetes: 6.1 % ≤ glycated hemoglobin A1c (HbA1c) ≤ 6.4 % and / or increased fasting plasma glucose (FPG): 6.1 mM ≤ FPG ≤ 6.9 mM and / or abnormal glucose tolerance (7.8 mM ≤ 2 hour plasma glucose (PG) ≤ 11.0 mmol)
-
Weekly training status <150 minutes
Exclusion Criteria:
-
BMI <25 kg/m2
-
Diabetes
-
Pregnancy and breastfeeding
-
Treatment with medicine, there influence glucose metabolism
-
Decreased liver function (liver transaminases > 3 times of limit of normal)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Diabetes Research, Gentofte Hospital | Hellerup | Denmark | 2900 |
Sponsors and Collaborators
- University Hospital, Gentofte, Copenhagen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-4-2013-079