An interventional study of 12h fasting and 36h fasting in Healthy, Obesity and Type 2 Diabetes Mellitus, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Other
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.
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:
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).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 80 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
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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
Age \>18 years; BMI 20-27 kg/m2; Fasting plasma Glucose \<110 mg/dL
Behavioral: 12h fasting · Behavioral: 36h fasting
Age \>18 years; BMI \>30 kg/m2; Fasting Plasma Glucose \<110 mg/dL
Behavioral: 12h fasting · Behavioral: 36h fasting
Age \>18 years; Diagnosed Type 2 Diabetes mellitus (diet or a monotherapy or combination of metformin, DPP-4-inhibitors or sulfonylurea)
Behavioral: 12h fasting · Behavioral: 36h fasting
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 · Behavioral: 36h fasting
12h fasting (overnight)
36h fasting ( one day and two nights fasting)
change of 2h glucose levels
Difference in the change of 2h glucose levels in an oral glucose tolerance test
Time frame: after 12 and 36 hours of fasting
changes in insulin sensitivity (QUICKI)
differences in QUICKI
Time frame: after 12 and 36 hours of fasting
changes in insulin sensitivity (Matsuda Index)
differences in Matsuda Index
Time frame: after 12 and 36 hours of fasting
changes in insulin sensitivity (ISI)
differences in ISI
Time frame: after 12 and 36 hours of fasting
changes in insulin sensitivity (HOMA-Index)
differences in HOMA-Index
Time frame: after 12 and 36 hours of fasting
Changes in glycaemic pattern
differences in area under the curve (AUC) of glycaemic pattern in Oral glucose tolerance test
Time frame: after 12 and 36 hours of fasting
Changes in body composition
differences in bioimpedance analysis
Time frame: after 12 and 36 hours of fasting
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Medical University of Graz