Time-restricted eating and circadian regulation of energy metabolism in type 2 diabetes (TR-EAT study) - TR-EAT

niversitätsklinikum Heidelberg0 个研究点目标入组 40 人开始时间: 2022年3月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

•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 [‰]

发起方

niversitätsklinikum Heidelberg