Status:
COMPLETED
Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes
Lead Sponsor:
Medical University of Graz
Conditions:
Healthy
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04283318
Start Date
June 13 2018
End Date
February 28 2022
Last Update
March 2 2022
Active Locations (1)
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1
Medical University of Graz
Graz, Austria, 8036