Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes (PROLOG)

The Effects of Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Obesity; Type 2 Diabetes Mellitus; Type 1 Diabetes
• Intervention / Treatment: Behavioral: 12h fasting; Behavioral: 36h fasting

Detailed Description

In this clinical study, we want to examine the effects of different fasting periods (12 hours versus 36 hours) on blood sugar levels and other metabolic parameters and hormones. For this the following investigations are carried out:

• Oral glucose tolerance test with detailed laboratory evaluation
• Bio-impedance measurement to determine body composition (muscle and fat mass)

The examinations are carried out on 4 different cohorts (normal healthy persons, obese patients, patients with type 2 diabetes and patients with type 1 diabetes).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Gender: Both, male and female Minimum Age: 18 years

Inclusion Criteria Cohort I (Healthy, non-obese subjects) Age >18 years; body mass index in the range of 20.0-27.0 kg/m2; fasting plasma glucose <110mg/dL

Inclusion criteria cohort II (Obese subjects) Age >18 years; body mass index >30 kg/m2; fasting plasma glucose <110mg/dL

Inclusion Criteria Cohort III (Cohort with subjects with Type 2 Diabetes Mellitus) Age >18 years; established Diabetes mellitus type 2 on either diet or a monotherapy or combination of metformin, Dipeptidylpeptidase (DPP)-4-inhibitors or sulfonylurea

Inclusion Criteria Cohort IV (Cohort with subjects with Type 1 Diabetes Mellitus) Age >18 years; diagnosed with Type 1 Diabetes Mellitus >12 months; treated with multiple daily Insulin injectioins (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; HbA1c <9.5%; 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

Exclusion Criteria (for all participants) History of cardiovascular disease; acute or chronic inflammatory disorder; heavy drinking (more than 15 drinks/week); dietary restrictions (e.g. vegetarianism and vegan); insulin Treatment (excluded subjects with Type 1 Diabetes Mellitus); corticosteroid therapy; known malignancy; women who are pregnant, breast-feeding or trying to become pregnant; history of any chronic disease process that could interfere with interpretation of study results; therapy with antidepressants within past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy; Age >18 years; BMI 20-27 kg/m2; Fasting plasma Glucose <110 mg/dL	Behavioral: 12h fasting; 12h fasting (overnight); Behavioral: 36h fasting; 36h fasting ( one day and two nights fasting)
Other: Obese people; Age >18 years; BMI >30 kg/m2; Fasting Plasma Glucose <110 mg/dL	Behavioral: 12h fasting; 12h fasting (overnight); Behavioral: 36h fasting; 36h fasting ( one day and two nights fasting)
Other: Type 2 Diabetes; Age >18 years; Diagnosed Type 2 Diabetes mellitus (diet or a monotherapy or combination of metformin, DPP-4-inhibitors or sulfonylurea)	Behavioral: 12h fasting; 12h fasting (overnight); Behavioral: 36h fasting; 36h fasting ( one day and two nights fasting)
Other: Type 1 Diabetes; 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 fasting; 12h fasting (overnight); Behavioral: 36h fasting; 36h fasting ( one day and two nights fasting)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in insulin sensitivity (QUICKI)	differences in QUICKI	after 12 and 36 hours of fasting
changes in insulin sensitivity (Matsuda Index)	differences in Matsuda Index	after 12 and 36 hours of fasting
changes in insulin sensitivity (ISI)	differences in ISI	after 12 and 36 hours of fasting
changes in insulin sensitivity (HOMA-Index)	differences in HOMA-Index	after 12 and 36 hours of fasting
Changes in glycaemic pattern	differences in area under the curve (AUC) of glycaemic pattern in Oral glucose tolerance test	after 12 and 36 hours of fasting
Changes in body composition	differences in bioimpedance analysis	after 12 and 36 hours of fasting

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Harald Sourij, MD, Medical University of Graz, Auenbruggerplatz 15

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2018
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; obese; glucose metabolism; starvation; Type 1 diabetes mellitus; healthy people
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: HS-2018-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No