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

Primary Purpose

Healthy, Obesity, Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
12h fasting
36h fasting
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy focused on measuring starvation, healthy people, obese, Type 2 diabetes mellitus, glucose metabolism, Type 1 diabetes mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Healthy

Obese people

Type 2 Diabetes

Type 1 Diabetes

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

changes in insulin sensitivity (QUICKI)
differences in QUICKI
changes in insulin sensitivity (Matsuda Index)
differences in Matsuda Index
changes in insulin sensitivity (ISI)
differences in ISI
changes in insulin sensitivity (HOMA-Index)
differences in HOMA-Index
Changes in glycaemic pattern
differences in area under the curve (AUC) of glycaemic pattern in Oral glucose tolerance test
Changes in body composition
differences in bioimpedance analysis

Full Information

First Posted
February 18, 2019
Last Updated
February 28, 2022
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04283318
Brief Title
Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes
Acronym
PROLOG
Official Title
The Effects of Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Obesity, Type 2 Diabetes Mellitus, Type 1 Diabetes
Keywords
starvation, healthy people, obese, Type 2 diabetes mellitus, glucose metabolism, Type 1 diabetes mellitus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy
Arm Type
Other
Arm Description
Age >18 years; BMI 20-27 kg/m2; Fasting plasma Glucose <110 mg/dL
Arm Title
Obese people
Arm Type
Other
Arm Description
Age >18 years; BMI >30 kg/m2; Fasting Plasma Glucose <110 mg/dL
Arm Title
Type 2 Diabetes
Arm Type
Other
Arm Description
Age >18 years; Diagnosed Type 2 Diabetes mellitus (diet or a monotherapy or combination of metformin, DPP-4-inhibitors or sulfonylurea)
Arm Title
Type 1 Diabetes
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
12h fasting
Intervention Description
12h fasting (overnight)
Intervention Type
Behavioral
Intervention Name(s)
36h fasting
Intervention Description
36h fasting ( one day and two nights fasting)
Primary Outcome Measure Information:
Title
change of 2h glucose levels
Description
Difference in the change of 2h glucose levels in an oral glucose tolerance test
Time Frame
after 12 and 36 hours of fasting
Secondary Outcome Measure Information:
Title
changes in insulin sensitivity (QUICKI)
Description
differences in QUICKI
Time Frame
after 12 and 36 hours of fasting
Title
changes in insulin sensitivity (Matsuda Index)
Description
differences in Matsuda Index
Time Frame
after 12 and 36 hours of fasting
Title
changes in insulin sensitivity (ISI)
Description
differences in ISI
Time Frame
after 12 and 36 hours of fasting
Title
changes in insulin sensitivity (HOMA-Index)
Description
differences in HOMA-Index
Time Frame
after 12 and 36 hours of fasting
Title
Changes in glycaemic pattern
Description
differences in area under the curve (AUC) of glycaemic pattern in Oral glucose tolerance test
Time Frame
after 12 and 36 hours of fasting
Title
Changes in body composition
Description
differences in bioimpedance analysis
Time Frame
after 12 and 36 hours of fasting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Sourij, MD
Organizational Affiliation
Medical University of Graz, Auenbruggerplatz 15
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

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

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