Center for Diabetes Research, Gentofte Hospital
Hellerup, 2900, Denmark
Completed
NCT Number: NCT02212665
Life Without Diabetes
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
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
High 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
BehavioralPrimary outcomes
-
Changes in insulin sensitivity
Time frame: 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 outcomes
-
Changes in oxygen peak oxygen uptake
Time frame: At baseline and after 12 weeks
Assessed from a physical fitness test (VO2peak)
-
Changes in glycaemic control
Time frame: At baseline and after 12 weeks
Measured as fasting plasma glucose, HbA1c
-
Changes in key proteins in glucose and fat metabolism (Skeletal muscle)
Time frame: At baseline and after 12 weeks
Expression/content of key proteins in skeletal muscle tissure (AU units)
-
Changes in body weight (kg)
Time frame: 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)
Time frame: At baseline and after 12 weeks
Expression/content of key proteins in adipose tissue (AU units)
-
Patient-reported outcome measure
Time frame: 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.
Sponsors and collaborators
Lead sponsor
University Hospital, Gentofte, Copenhagen
Other
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Aug 8, 2014
- Registry last updated
- Jul 9, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.