NCT02420054

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

6 years

First QC Date

April 10, 2015

Last Update Submit

February 8, 2021

Conditions

Diabetes MellitusNon-alcoholic Fatty Liver DiseaseMetabolic SyndromeObesity

Keywords

intermittent fastingalternate day fastingdiabetes mellitusnon-alcoholic fatty liver diseaseinsulin sensitivity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Glycogen Content in Skeletal Muscle after a Day of Eating and after a Day of Fasting

    46 days

  • Change from Baseline in Fat Content in the Liver and Visceral Fat after 20 Days of Intermittent Fasting

    23 days

  • Insulin signalling cascade proteins

    46 days

Study Arms (2)

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.

Behavioral: Intermittent fasting

Time control

ACTIVE COMPARATOR

A time control period.

Other: Time control

Interventions

Intermittent fastingBEHAVIORAL

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.

Intermittent fasting
Time controlOTHER

Time control period with no change in eating habits.

Time control

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 28-35
  • Type 2 diabetes or metabolically healthy
  • Diet or orally administered treatment for type 2 diabetes

You may not qualify if:

  • Regular physical activity
  • Other diseases than type 2 diabetes
  • insulin treatment
  • alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xlab, Department of Biomedical Sciences, University of Copenhagen

Copenhagen, 2200, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 36531168DERIVED

MeSH Terms

Conditions

Diabetes MellitusNon-alcoholic Fatty Liver DiseaseMetabolic SyndromeObesityIntermittent FastingInsulin Resistance

Interventions

Flowering time control protein FCA, Arabidopsis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFatty LiverLiver DiseasesDigestive System DiseasesHyperinsulinismOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Study Officials

  • Flemming Dela, MD, DMSc

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 17, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)