Short Term Intermittent Fasting and Insulin Resistance

Obesity Clinical Trial

— IFAST  

Official title:

Effects of Short Term Intermittent Fasting on Insulin Resistance in Type 2 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02420054
• Other study ID #: Intermittent Fasting
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: June 2021

Study information

• Verified date: February 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the effect of intermittent fasting on insulin secretion and insulin sensitivity in skeletal muscle and fat distribution.

Description:

Approximately 250.000 patients are diagnosed with type 2 diabetes (T2DM) in Denmark, and world-wide close to 350 million people suffer from diabetes. T2DM develops in genetically susceptible individuals as a result of excess energy intake and insufficient amount of daily physical activity. The pathophysiology encompasses a mismatch between the insulin secretory capacity and insulin sensitivity, predominantly manifested in skeletal muscle as insulin resistance. T2DM is associated with increased morbidity and mortality.

The disease is triggered by the individual lifestyle, and thereby the potential for prevention and reversal of the disease in its early years after diagnosis is quite large.

One potential way to improve glucose homeostasis is by intermittent fasting, also known as alternate day fasting. Intermittent fasting means switching between eating and fasting, and it is a variation of calorie restriction. Intermittent fasting has been studied in animals. Together with calorie restriction, intermittent fasting is the most efficient way to expand lifespan of many animal species without genetically altering them. A wide range of age related changes are delayed including beneficial effects on hypertension, degenerative brain disease, immune responses, DNA repair capacity and glucose homeostasis. Fat redistribution with fat translocating from between the organs and the liver to the subcutis.

Little is known about intermittent fasting in humans. In 2005 the investigators experimentally tested this concept in young healthy males and found that 15 days of alternating days with fast and food intake increased insulin sensitivity by 16% without any changes in body weight.

The explanation could be oscillations in cellular energy stores. Skeletal muscle contains approximately 80% of the stored glycogen alone by virtue of the muscle mass. The liver has a higher glycogen concentration, but it is much smaller. A single prolonged (>24 hrs) day of fasting may not decrease muscle glycogen, while the decrease in the liver is very fast. A muscle glycogen lowering effect of continued intermittent fasting would be expected, and experimentally indicated.

The intermittent fasting method may appeal to some patients, who do not exercise, and the need for testing this intervention in patients with type 2 diabetes is obvious.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Fatty Liver
• Insulin Resistance
• Liver Diseases
• Metabolic Syndrome
• Non-alcoholic Fatty Liver Disease
• Obesity

Intervention

Behavioral:
• Intermittent fasting
Alternate day fasting (ADF) (water permitted) for 3 weeks with double energy intake every other day. Followed by ADF for 3 weeks with ad libitum diet on eating days.

Other:
• Time control
Time control period with no change in eating habits.

Locations

Country	Name	City	State
Denmark	Xlab, Department of Biomedical Sciences, University of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Insulin Sensitivity after 20 days of intermittent fasting.	An euglycemic hyperinsulinemic clamp is performed at day 1 and repeated at day 23 after a control period with no change in the diet. Baseline insulin sensitivity is determined based on these two measurements. The euglycemic hyperinsulinemic clamp is repeated at day 46 after the intermittent fasting period (day 25-44) and two days (day 24 and 45) with a normal diet.	46 days
Primary	Change of insulin secretion	IVGTT performed at baseline, after intermittent fasting without weight loss and again after intermittent fasting with weight loss	46 days
Secondary	Glycogen Content in Skeletal Muscle after a Day of Eating and after a Day of Fasting	Analysis of glycogen content from muscle biopsies obtained after a day of fasting and after a day of eating during the intermittent fasting period.	46 days
Secondary	Change from Baseline in Fat Content in the Liver and Visceral Fat after 20 Days of Intermittent Fasting	Fat content measured by magnetic resonance spectroscopy.	23 days
Secondary	Insulin signalling cascade proteins	By Western blot determine any change in proteins relevant for insulin signalling and turnover of intramyocellular lipids.	46 days