Prevention of Developing Type 2 Diabetes
Conditions
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).
Interventions
BEHAVIORALHigh intense interval training
BEHAVIORALIncreased daily activity detected by the pedometer
BEHAVIORALIncreased daily activity detected by the pedometer+HIIT
BEHAVIORALIncreased daily activity detected by the pedometer+group intervention
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 oxygen peak oxygen uptake | At baseline and after 12 weeks | Assessed from a physical fitness test (VO2peak) |
| 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. |
| Changes in body weight (kg) | At baseline and after 12 weeks | Measured by Dual-energy X-ray Absorptiometry, DXA |
Countries
Denmark
Outcome results
None listed