Diabetes MellitusIFASTNCT02420054
Short Term Intermittent Fasting and Insulin Resistance
A study testing Intermittent fasting in people with Diabetes Mellitus and Non-alcoholic Fatty Liver Disease, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
- What is being tested?
- Intermittent fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 28-35
- Type 2 diabetes or metabolically healthy
- Diet or orally administered treatment for type 2 diabetes
Who cannot join
- Regular physical activity
- Other diseases than type 2 diabetes
- insulin treatment
- alcohol abuse
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Xlab, Department of Biomedical Sciences, University of Copenhagen
Copenhagen, 2200
About this study
Official title: Effects of Short Term Intermittent Fasting on Insulin Resistance in Type 2 Diabetes
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.
Read the 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.
- Being tested
- Intermittent fasting, Time control
- Keywords
- intermittent fasting, alternate day fasting, diabetes mellitus, non-alcoholic fatty liver disease, insulin sensitivity
- Medical subject headings
- Diabetes Mellitus, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Obesity, Intermittent Fasting, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fastingBehavioural
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 controlOther
Time control period with no change in eating habits.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting | Active comparator | Intermittent fasting conducted by a group of subjects with type 2 diabetes mellitus and an age- and BMI matched control group. Receives: Behavioral: Intermittent fasting |
| Time control | Active comparator | A time control period. Receives: Other: Time control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 46 days
Change of insulin secretion
IVGTT performed at baseline, after intermittent fasting without weight loss and again after intermittent fasting with weight loss
Measured: 46 days
Secondary outcomes (3)
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.
Measured: 46 days
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.
Measured: 23 days
Insulin signalling cascade proteins
By Western blot determine any change in proteins relevant for insulin signalling and turnover of intramyocellular lipids.
Measured: 46 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Principal investigator, Flemming Dela, University of Copenhagen
- Investigators
- Flemming Dela, MD, DMSc, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420054
- Sponsor's protocol ID
- Intermittent Fasting
- Acronym
- IFAST
- Status last verified
- Feb 2021
- First submitted
- 10 Apr 2015
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36531168
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short Term Intermittent Fasting on Insulin Resistance in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02420054
- Acronym / sponsor ID
- IFAST / Intermittent Fasting
- Keywords
- intermittent fasting, alternate day fasting, diabetes mellitus, non-alcoholic fatty liver disease, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting | Active comparator | Behavioral: Intermittent fastingIntermittent fasting conducted by a group of subjects with type 2 diabetes mellitus and an age- and BMI matched control group. |
| Time control | Active comparator | Other: Time controlA time control period. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI 28-35
- Type 2 diabetes or metabolically healthy
- Diet or orally administered treatment for type 2 diabetes
Key exclusion criteria (4 listed)
- Regular physical activity
- Other diseases than type 2 diabetes
- insulin treatment
- alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent fastingAlternate 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. | Behavioural | Intermittent fasting |
| Time controlTime control period with no change in eating habits. | Other | Time control |
Primary outcome
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.
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
3 secondary outcomes
Glycogen Content in Skeletal Muscle after a Day of Eating and after a Day of Fasting
Time frame: 46 days
Change from Baseline in Fat Content in the Liver and Visceral Fat after 20 Days of Intermittent Fasting
Time frame: 23 days
Insulin signalling cascade proteins
Time frame: 46 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 36531168Ingersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flemming Dela, MD, DMSc principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent fasting in people with Diabetes Mellitus and Non-alcoholic Fatty Liver Disease, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Insulin Sensitivity after 20 days of intermittent fasting. (time frame: 46 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021; AzTrials last refreshed its copy on 1 Nov 2026.