Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes
NCT ID: NCT04283318
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2018-06-13
2022-02-28
Brief Summary
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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.
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Detailed Description
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* 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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Healthy
Age \>18 years; BMI 20-27 kg/m2; Fasting plasma Glucose \<110 mg/dL
12h fasting
12h fasting (overnight)
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
12h fasting
12h fasting (overnight)
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)
12h fasting
12h fasting (overnight)
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
12h fasting
12h fasting (overnight)
36h fasting
36h fasting ( one day and two nights fasting)
Interventions
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12h fasting
12h fasting (overnight)
36h fasting
36h fasting ( one day and two nights fasting)
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
Yes
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Harald Sourij, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz, Auenbruggerplatz 15
Locations
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Medical University of Graz
Graz, , Austria
Countries
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Other Identifiers
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HS-2018-01
Identifier Type: -
Identifier Source: org_study_id
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