Life Without Diabetes
- Conditions
- Prevention of Developing Type 2 Diabetes
- Interventions
- Behavioral: Increased daily activity detected by the pedometerBehavioral: Increased daily activity detected by the pedometer+group interventionBehavioral: High intense interval trainingBehavioral: Increased daily activity detected by the pedometer+HIIT
- Registration Number
- NCT02212665
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- 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
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Increased daily activity detected by the pedometer Increased daily activity detected by the pedometer 10.000 steps a day Increased daily activity (pedometer)+group intervention Increased daily activity detected by the pedometer+group intervention 10.000 steps + group intervention High intense interval training (HIIT) High intense interval training 3 x 20 sec, 3 x week Increased daily activity detected by te pedometer+HIIT Increased daily activity detected by the pedometer+HIIT 10.000 steps + 3 x 20 sec, 3 x week
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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)
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 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
Trial Locations
- Locations (1)
Center for Diabetes Research, Gentofte Hospital
🇩🇰Hellerup, Denmark