Metabolic and Hormonal Effects of 5:2 Intermittent Fasting
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02450097|
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : December 15, 2017
The aim of the present study is to investigate in subjects with and without type 2 diabetes the effect of calorie restriction (CR) according to the 5:2 method for 6 months (every week two days caloric fasting with 500 calories for women and 600 calories for men and five days of normal caloric intake) on risk markers for cardiovascular disease and certain cancers (hyperinsulinemia, insulin resistance, IGF-1, IGFBP-1, IGFBP-2, glucose, HbA1c, blood lipids, markers of inflammation and oxidative stress) and on peptides regulating glucose metabolism and appetite as well as the effect on blood pressure, body composition, waist- and hip- circumference. DNA will also be analysed at the start and after 6 months to investigate any epigenetic effects.
After completed study there will be a follow up after additional 6 months.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Diabetes Type 2||Other: Caloric restriction||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabolic and Hormonal Effects of 5:2 Intermittent Fasting in Patients With Type 2 Diabetes and Subjects With Adiposity|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||December 2017|
Intermittent Caloric restriction in 3 Groups:
I- 40 patients with diabetes type 2 BMI 25.1-37 II- 40 non diabetic over weight subjects with BMI 25.1-37 III- 20 non diabetic subject with BMI 23.1 - 25 and visceral fat
Other: Caloric restriction
- Change from baseline in fasting serum insulin in 6 months. [ Time Frame: 6 months ]Serum insulin will be measured using a radioimmunoassay (RIA; Pharmacia insulin RIA 100, Pharmacia Diagnostics, Uppsala, Sweden).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450097
|Karolinska University Hospital|
|Stockholm, Sweden, 17176|
|Principal Investigator:||Kerstin Brismar, Professor||Karolinska University Hospital|