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Short Term Intermittent Fasting and Insulin Resistance (IFAST)

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ClinicalTrials.gov Identifier: NCT02420054
Recruitment Status : Unknown
Verified May 2017 by Flemming Dela, University of Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2015
Last Update Posted : May 18, 2017
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Flemming Dela, University of Copenhagen

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Non-alcoholic Fatty Liver Disease Metabolic Syndrome Obesity Behavioral: Intermittent fasting Other: Time control Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Short Term Intermittent Fasting on Insulin Resistance in Type 2 Diabetes
Study Start Date : April 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : April 2018


Arm Intervention/treatment
Active Comparator: Intermittent fasting
Intermittent fasting conducted by a group of subjects with type 2 diabetes mellitus and an age- and BMI matched control group.
Behavioral: Intermittent fasting
Eating every other day for at total of 20 days.

Active Comparator: Time control
A time control period.
Other: Time control
Time control period with no change in eating habits.




Primary Outcome Measures :
  1. Change from Baseline in Insulin Sensitivity after 20 days of intermittent fasting. [ Time Frame: 46 days ]
    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.

  2. Change of insulin secretion [ Time Frame: 46 days ]
    IVGTT performed at baseline, after intermittent fasting without weight loss and again after intermittent fasting with weight loss


Secondary Outcome Measures :
  1. Glycogen Content in Skeletal Muscle after a Day of Eating and after a Day of Fasting [ Time Frame: 46 days ]
    Analysis of glycogen content from muscle biopsies obtained after a day of fasting and after a day of eating during the intermittent fasting period.

  2. Change from Baseline in Fat Content in the Liver and Visceral Fat after 20 Days of Intermittent Fasting [ Time Frame: 23 days ]
    Fat content measured by magnetic resonance spectroscopy.

  3. Insulin signalling cascade proteins [ Time Frame: 46 days ]
    By Western blot determine any change in proteins relevant for insulin signalling and turnover of intramyocellular lipids.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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): NCT02420054


Locations
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Denmark
Xlab, Department of Biomedical Sciences, University of Copenhagen
Copenhagen N, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Herlev Hospital
Investigators
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Principal Investigator: Flemming Dela, MD, DMSc University of Copenhagen

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Responsible Party: Flemming Dela, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02420054     History of Changes
Other Study ID Numbers: Intermittent Fasting
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Flemming Dela, University of Copenhagen:
intermittent fasting
alternate day fasting
diabetes mellitus
non-alcoholic fatty liver disease
insulin sensitivity

Additional relevant MeSH terms:
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Diabetes Mellitus
Insulin Resistance
Insulin
Metabolic Syndrome
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Digestive System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs