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

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ClinicalTrials.gov Identifier: NCT04283318
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Healthy Obesity Type 2 Diabetes Mellitus Type 1 Diabetes Behavioral: 12h fasting Behavioral: 36h fasting Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

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)

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)

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)




Primary Outcome Measures :
  1. change of 2h glucose levels [ Time Frame: after 12 and 36 hours of fasting ]
    Difference in the change of 2h glucose levels in an oral glucose tolerance test


Secondary Outcome Measures :
  1. changes in insulin sensitivity (QUICKI) [ Time Frame: after 12 and 36 hours of fasting ]
    differences in QUICKI

  2. changes in insulin sensitivity (Matsuda Index) [ Time Frame: after 12 and 36 hours of fasting ]
    differences in Matsuda Index

  3. changes in insulin sensitivity (ISI) [ Time Frame: after 12 and 36 hours of fasting ]
    differences in ISI

  4. changes in insulin sensitivity (HOMA-Index) [ Time Frame: after 12 and 36 hours of fasting ]
    differences in HOMA-Index

  5. Changes in glycaemic pattern [ Time Frame: after 12 and 36 hours of fasting ]
    differences in area under the curve (AUC) of glycaemic pattern in Oral glucose tolerance test

  6. Changes in body composition [ Time Frame: after 12 and 36 hours of fasting ]
    differences in bioimpedance analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283318


Contacts
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Contact: Norbert Tripolt, PhD +43316385 ext 78038 norbert.tripolt@medunigraz.at
Contact: Harald Sourij, MD +4331638581310 ext 81310 ha.sourij@medunigraz.at

Locations
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Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Norbert Tripolt, PhD    31638578038    norbert.tripolt@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Harald Sourij, MD Medical University of Graz, Auenbruggerplatz 15
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT04283318    
Other Study ID Numbers: HS-2018-01
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Graz:
starvation
healthy people
obese
Type 2 diabetes mellitus
glucose metabolism
Type 1 diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases