Life Without Diabetes
1 other identifier
interventional
59
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
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
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 6, 2014
CompletedFirst Posted
Study publicly available on registry
August 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 9, 2021
July 1, 2021
3.9 years
August 6, 2014
July 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in insulin sensitivity
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
At baseline and after 12 weeks
Secondary Outcomes (6)
Changes in oxygen peak oxygen uptake
At baseline and after 12 weeks
Changes in glycaemic control
At baseline and after 12 weeks
Changes in key proteins in glucose and fat metabolism (Skeletal muscle)
At baseline and after 12 weeks
Changes in body weight (kg)
At baseline and after 12 weeks
Changes in key proteins in glucose and fat metabolism (Adipose fat tissure)
At baseline and after 12 weeks
- +1 more secondary outcomes
Study Arms (5)
High intense interval training (HIIT)
EXPERIMENTAL3 x 20 sec, 3 x week
Increased daily activity detected by the pedometer
EXPERIMENTAL10.000 steps a day
Increased daily activity detected by te pedometer+HIIT
EXPERIMENTAL10.000 steps + 3 x 20 sec, 3 x week
Increased daily activity (pedometer)+group intervention
EXPERIMENTAL10.000 steps + group intervention
Control group
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Diabetes Research, Gentofte Hospital
Hellerup, 2900, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc, ph.d-student
Study Record Dates
First Submitted
August 6, 2014
First Posted
August 8, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
July 9, 2021
Record last verified: 2021-07