Life Without Diabetes

Prevention of Developing Type 2 Diabetes Clinical Trial

Official title:

Life Without Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212665
• Other study ID #: H-4-2013-079
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2021
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Prevention of Developing Type 2 Diabetes

Intervention

Behavioral:
• High intense interval training

• Increased daily activity detected by the pedometer

• Increased daily activity detected by the pedometer+HIIT

• Increased daily activity detected by the pedometer+group intervention

Locations

Country	Name	City	State
Denmark	Center for Diabetes Research, Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in oxygen peak oxygen uptake	Assessed from a physical fitness test (VO2peak)	At baseline and after 12 weeks
Secondary	Changes in glycaemic control	Measured as fasting plasma glucose, HbA1c	At baseline and after 12 weeks
Secondary	Changes in key proteins in glucose and fat metabolism (Skeletal muscle)	Expression/content of key proteins in skeletal muscle tissure (AU units)	At baseline and after 12 weeks
Secondary	Changes in body weight (kg)	Measured by Dual-energy X-ray Absorptiometry, DXA	At baseline and after 12 weeks
Secondary	Changes in key proteins in glucose and fat metabolism (Adipose fat tissure)	Expression/content of key proteins in adipose tissue (AU units)	At baseline and after 12 weeks
Secondary	Patient-reported outcome measure	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.	At baseline and after 12 weeks