NCT04283318

Brief Summary

In a previous study investigating the effects of intermittent fasting, our research group found evidence for higher glucose excursions and a reduced insulin response after a 36 hour fasting period as compared to an overnight fasting period in healthy subjects. The aim of this research project is to investigate the effect of short and midterm fasting (12 hours versus 36 hours) on glucose metabolism, glucose regulatory hormones, insulin secretion and resting energy expenditure in healthy and obese people as well as in patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2019

Completed
1 year until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.7 years

First QC Date

February 18, 2019

Last Update Submit

February 28, 2022

Conditions

HealthyObesityType 2 Diabetes MellitusType 1 Diabetes

Keywords

starvationhealthy peopleobeseType 2 diabetes mellitusglucose metabolismType 1 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • change of 2h glucose levels

    Difference in the change of 2h glucose levels in an oral glucose tolerance test

    after 12 and 36 hours of fasting

Secondary Outcomes (6)

  • changes in insulin sensitivity (QUICKI)

    after 12 and 36 hours of fasting

  • changes in insulin sensitivity (Matsuda Index)

    after 12 and 36 hours of fasting

  • changes in insulin sensitivity (ISI)

    after 12 and 36 hours of fasting

  • changes in insulin sensitivity (HOMA-Index)

    after 12 and 36 hours of fasting

  • Changes in glycaemic pattern

    after 12 and 36 hours of fasting

  • +1 more secondary outcomes

Study Arms (4)

Healthy

OTHER

Age \>18 years; BMI 20-27 kg/m2; Fasting plasma Glucose \<110 mg/dL

Behavioral: 12h fastingBehavioral: 36h fasting

Obese people

OTHER

Age \>18 years; BMI \>30 kg/m2; Fasting Plasma Glucose \<110 mg/dL

Behavioral: 12h fastingBehavioral: 36h fasting

Type 2 Diabetes

OTHER

Age \>18 years; Diagnosed Type 2 Diabetes mellitus (diet or a monotherapy or combination of metformin, DPP-4-inhibitors or sulfonylurea)

Behavioral: 12h fastingBehavioral: 36h fasting

Type 1 Diabetes

OTHER

Age \>18 years; Diagnosed Type 1 Diabetes mellitus \>12 months; Treated with multiple daily Insulin injections (MDII) or continuous subcutaneous Insulin Infusion (CSII); Stable Insulin therapy as clinically assessed by the study physician C-Peptide negative defined as 0.3 nmol/L; No diabetic ketoacidosis within the last 12 months; No severe hypoglycaemia requiring external assistance within the last 12 months; Running on the FreeStyle Libre 1 (Abbott, USA) intermittently-viewed continuous Glucose Monitoring System (iCGM) as Standard of care for Glucose monitoring

Behavioral: 12h fastingBehavioral: 36h fasting

Interventions

12h fastingBEHAVIORAL

12h fasting (overnight)

HealthyObese peopleType 1 DiabetesType 2 Diabetes
36h fastingBEHAVIORAL

36h fasting ( one day and two nights fasting)

HealthyObese peopleType 1 DiabetesType 2 Diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Diabetes Mellitus, Type 1Starvation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesMalnutrition

Study Officials

  • Harald Sourij, MD

    Medical University of Graz, Auenbruggerplatz 15

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 25, 2020

Study Start

June 13, 2018

Primary Completion

February 26, 2020

Study Completion

February 28, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

AU(1)