PROLOG: Prolonged Fasting on Glucose Metabolism and Hormonal Regulation in Healthy, Obese and Subjects With Type 2 Diabetes
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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)
|
| Other: 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)
|
| Other: 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)
|
| Other: 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)
|
Outcome Measures
Primary Outcome Measures
- change of 2h glucose levels [after 12 and 36 hours of fasting]
Difference in the change of 2h glucose levels in an oral glucose tolerance test
Secondary Outcome Measures
- changes in insulin sensitivity (QUICKI) [after 12 and 36 hours of fasting]
differences in QUICKI
- changes in insulin sensitivity (Matsuda Index) [after 12 and 36 hours of fasting]
differences in Matsuda Index
- changes in insulin sensitivity (ISI) [after 12 and 36 hours of fasting]
differences in ISI
- changes in insulin sensitivity (HOMA-Index) [after 12 and 36 hours of fasting]
differences in HOMA-Index
- Changes in glycaemic pattern [after 12 and 36 hours of fasting]
differences in area under the curve (AUC) of glycaemic pattern in Oral glucose tolerance test
- Changes in body composition [after 12 and 36 hours of fasting]
differences in bioimpedance analysis
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Graz | Graz | Austria | 8036 |
Sponsors and Collaborators
- Medical University of Graz
Investigators
- Principal Investigator: Harald Sourij, MD, Medical University of Graz, Auenbruggerplatz 15
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS-2018-01