Clinical trial NCT02420054: Short Term Intermittent Fasting and Insulin Resistance
Official title: Effects of Short Term Intermittent Fasting on Insulin Resistance in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Obesity
Keywords: intermittent fasting
alternate day fasting
diabetes mellitus
non-alcoholic fatty liver disease
insulin sensitivity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2015-04-17
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline in Insulin Sensitivity after 20 days of intermittent fasting.
timeFrame: 46 days
measure: Change of insulin secretion
timeFrame: 46 days
Secondary outcomes:
measure: Glycogen Content in Skeletal Muscle after a Day of Eating and after a Day of Fasting
timeFrame: 46 days
measure: Change from Baseline in Fat Content in the Liver and Visceral Fat after 20 Days of Intermittent Fasting
timeFrame: 23 days
measure: Insulin signalling cascade proteins
timeFrame: 46 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Xlab, Department of Biomedical Sciences, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Flemming Dela, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: