Short Term Intermittent Fasting and Insulin Resistance

NCT ID: NCT02420054

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2021-06-30

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.

Conditions

Diabetes Mellitus; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome; Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intermittent fasting

Intermittent fasting conducted by a group of subjects with type 2 diabetes mellitus and an age- and BMI matched control group.

Group Type: ACTIVE_COMPARATOR

Intermittent fasting

Intervention Type: BEHAVIORAL

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.

Time control

A time control period.

Group Type: ACTIVE_COMPARATOR

Time control

Intervention Type: OTHER

Time control period with no change in eating habits.

Interventions

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.

Intervention Type: BEHAVIORAL

Time control

Time control period with no change in eating habits.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Herlev Hospital

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Flemming Dela

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flemming Dela, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Xlab, Department of Biomedical Sciences, University of Copenhagen

Copenhagen, , Denmark

Countries

Denmark

References

Ingersen A, Helset HR, Calov M, Chabanova E, Harreskov EG, Jensen C, Hansen CN, Prats C, Helge JW, Larsen S, Dela F. Metabolic effects of alternate-day fasting in males with obesity with or without type 2 diabetes. Front Physiol. 2022 Dec 1;13:1061063. doi: 10.3389/fphys.2022.1061063. eCollection 2022.

Reference Type: DERIVED

PMID: 36531168 (View on PubMed)

Other Identifiers

Intermittent Fasting

Identifier Type: -

Identifier Source: org_study_id