diabetes mellitus type 2 E11
Conditions
Interventions
Group 1: early time-restricted eating, 3 months
Group 2: late time-restricted eating, 3 months
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age between = 18 and = 75 years BMI between 22 and 45 kg/m2 Individuals with manifest diabetes mellitus type 2 and confirmed diagnosis according to 2011 DDG criteria (i.e., HbA1c = 6.5% with exclusion of alterations of HbA1c, above 200 mg/dl in 2-hour oGTT, pathological fasting glucose above 126 mg/dl, pathological spontaneous glucose of = 200 mg/dl at least twice) and meeting the following criteria: Diagnosis = 1 year, No therapy with insulin, glitazones, or sulfonylurea, HbA1c = 6.5 - 9%, Ability to consent, Understanding of study explanations and instructions.
Exclusion criteria
Exclusion criteria: General exclusion criteria: Secondary forms of diabetes (ADA criteria type 3 B-H), Patients on insulin therapy, Current pregnancy, Acute infections/fever, Immunosuppressive therapy, Known severe psychiatric illness requiring treatment (e.g. personality disorders, schizophrenia, depression), Known dependence on alcohol or other drugs, Severe cardiac, renal or liver disease, NYHA stage IV, Known non-diabetic liver disease (e.g. PBC, PSC, M. Wilson, hemochromatosis, autoimmune hepatitis), Severe pAVK (stage IV), Known non-diabetic glomerulopathy, Known malignant cancer in the past 5 years, Known infectious hepatitis B, C, E, HIV, Known other autoimmune diseases, Current participation in an intervention trial, Known anemia or bone marrow disorders, Exclusion criteria for clamp testing: History of thrombosis or peripheral pulmonary artery embolism, Routine clinical chemistry laboratory values: = 80% of lower reference value: ferritin, iron, leukocytes, Hb, Hkt, erythrocytes, platelets, (residual) blood alcohol detection [‰]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in energy metabolism | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of shifting meal time on energy metabolism Accumulation of reactive metabolites and their detoxification systemically and in skeletal muscle Intestinal microbiome and the alteration of postprandial intestinal peptide secretion Expression levels of genes relevant for circadian rhythmicity, "clock genes" | — |
Countries
Germany
Contacts
Public ContactAlba Sulaj
Universitätsklinikum Heidelberg
Outcome results
None listed