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

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes Mellitus; Healthy; Type 1 Diabetes

• Registration Number: NCT04283318
• Lead Sponsor: Medical University of Graz

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.

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 Timeline

• Study Start: 2018-06-13
• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-25
• Primary Completion: 2020-02-26
• Status Verified: 2022-02
• Study Completion: 2022-02-28
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change of 2h glucose levels	after 12 and 36 hours of fasting	Difference in the change of 2h glucose levels in an oral glucose tolerance test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria