Phase
Condition
Diabetes Prevention
Diabetes And Hypertension
Diabetes Mellitus, Type 2
Treatment
Control diet
Intermittent fasting
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body mass index (BMI) between 25 - 40 kg/m²
Understand and voluntarily sign an informed consent document prior to any studyrelated assessments/procedures.
Subjects with prediabetes (IFG and/or IGT, HbA1c 5,4 % - 6,4 %, subphenotype cluster 3 or 5) or
Subjects with type 2 diabetes mellitus (diagnosed <5 years prior to screening),HbA1c 6.0% - 9.5%, not receiving insulin or thiazolidinediones, and with anappropriate washout period for all other antidiabetic medications)
Exclusion
Exclusion Criteria:
Subjects with diabetes mellitus type 1 (GAD-, IA2-AB positive)
Women during pregnancy and lactation
Treamtent with any medication effecting on glucose metabolism like anti-diabeticdrugs or steroids
Subjects with a haemoglobin (Hb) ≤ 11.5 g/dl (for males) and Hb ≤ 10.5 g/dl (forfemales) at screening
Any pancreatic disease
Medical history of cancer and/or treatment for cancer within the last 5 years.
Known current presence or history of severe neurological or psychiatric diseases,schizophrenia, bipolar disorder
Known history of bariatric surgery
Severe liver or kidney diseases (Alanine Aminotransferase (ALT [SGPT]), AspartateAminotransferase (AST [SGOT]) above 3 x upper limit of normal (ULN) or GlomerularFiltration Rate (eGFR) ≤ 60 ml/min (MDRD formula)
Systemic infection (CRP > 1 mg/dl)
Severe diabetic complications like chronic kidney disease (CKD), proliferatingretinopathy or symptomatic cardiovascular disease
Presence of any contraindication for the conduct of an MRI investigation, such ascardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system,metallic splinters in the eye, ferromagnetic or electronically operated activedevices like automatic cardioverter defibrillators, cochlear implants, insulin pumpsand nerve stimulators, prosthetic heart valves etc.
Persons with limited temperature sensation and / or elevated sensitivity to warmingof the body
Persons with a hearing disorder or a increased sensitivity for loud noises
Claustrophobia
Participation in other clinical trials or observation period of competing trials upto 30 days prior to this study
Refusal to get informed of unexpected detected pathological findings
Study Design
Connect with a study center
Charité Berlin - Department of Endocrinology and Metabolic Diseases
Berlin, 10117
GermanyActive - Recruiting
Universtiy Hospital Carl Gustav Carus
Dresden, 01307
GermanyActive - Recruiting
German Diabetes Center
Duesseldorf, 40225
GermanySite Not Available
German Diabetes Center
Düsseldorf, 40225
GermanyActive - Recruiting
Heidelberg University Hospital - Department of Endocrinology and Metabolism
Heidelberg, 69120
GermanyActive - Recruiting
University Hospital Leipzig - Clinic for Endocrinology and Nephrology
Leipzig, 04103
GermanyActive - Recruiting
University of Luebeck - Institute of Endocrinology and Diabetes
Luebeck, 23538
GermanySite Not Available
University of Luebeck - Institute of Endocrinology and Diabetes
Lübeck, 23538
GermanyActive - Recruiting
Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine
Munich, 80992
GermanyActive - Recruiting
University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)
Tuebingen, 72076
GermanySite Not Available
University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)
Tübingen, 72076
GermanyActive - Recruiting

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