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The Effects of prolonged Fasting on glucose metabolism and hormonal regulation in healthy, obese and subjects with type 1 and type 2 diabetes

The Effects of prolonged Fasting on glucose metabolism and hormonal regulation in healthy, obese and subjects with type 1 and type 2 diabetes - PROLOG

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00016148
Enrollment
80
Registered
2018-12-13
Start date
2018-06-13
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E11 E66

Interventions

Group 1: 36h Fasting

Sponsors

Medizinische Universität Graz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria Cohort I (Cohort with healthy, non-obese subjects) - Age >18 years - Body mass index in the range of 20.0 – 27.0 kg/m2 - Fasting plasma glucose 18 years - Body mass index > 30.0 kg/m2 - Fasting plasma glucose 18 years - established diabetes mellitus type 2 on either diet or a monotherapy or combination of metformin, DPP-4-inhibitors or sulfonylurea Inclusion Criteria Cohort IV (Cohort with Subjects with Type 1 Diabetes) - Age > 18 years - Diagnosed with type 1 diabetes > 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 - 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

Exclusion criteria: Exclusion criteria cohort I - Presence of any metabolic disease - Intake of any glucose lowering, lipid lowering or blood pressure lowering medication Exclusion criteria cohort II - Intake of any glucose lowering medication 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) - 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

Design outcomes

Primary

MeasureTime frame
Difference in 2-hour glucose in an oral glucose tolerance test after 12 and 36 hours of fasting

Secondary

MeasureTime frame
- Differences in insulin sensitivity (Matsuda Index, ISI, HOMA-Index, QUICKI) after 12 and 36 hours of fasting - Differences in glycaemic pattern (AUC in OGTT) after 12 and 36 hours of fasting - Differences in body composition after 12 and 36 hours of fasting

Countries

Austria

Contacts

Public ContactNorbert Tripolt

Medizinische Universität Graz

norbert.tripolt@medunigraz.at+43 316 385 78038

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 15, 2026