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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 22 February 2021
Main ID:  NCT02420054
Date of registration: 10/04/2015
Prospective Registration: No
Primary sponsor: University of Copenhagen
Public title: Short Term Intermittent Fasting and Insulin Resistance IFAST
Scientific title: Effects of Short Term Intermittent Fasting on Insulin Resistance in Type 2 Diabetes
Date of first enrolment: April 2015
Target sample size: 20
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02420054
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Name:     Flemming Dela, MD, DMSc
Address: 
Telephone:
Email:
Affiliation:  University of Copenhagen
Key inclusion & exclusion criteria

Inclusion Criteria:

- BMI 28-35

- Type 2 diabetes or metabolically healthy

- Diet or orally administered treatment for type 2 diabetes

Exclusion Criteria:

- Regular physical activity

- Other diseases than type 2 diabetes

- insulin treatment

- alcohol abuse



Age minimum: 40 Years
Age maximum: 65 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Diabetes Mellitus
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Obesity
Intervention(s)
Other: Time control
Behavioral: Intermittent fasting
Primary Outcome(s)
Change from Baseline in Insulin Sensitivity after 20 days of intermittent fasting. [Time Frame: 46 days]
Change of insulin secretion [Time Frame: 46 days]
Secondary Outcome(s)
Insulin signalling cascade proteins [Time Frame: 46 days]
Change from Baseline in Fat Content in the Liver and Visceral Fat after 20 Days of Intermittent Fasting [Time Frame: 23 days]
Glycogen Content in Skeletal Muscle after a Day of Eating and after a Day of Fasting [Time Frame: 46 days]
Secondary ID(s)
Intermittent Fasting
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Herlev Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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