Last updated: May 8, 2024
Sponsor: University Hospital Tuebingen
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes Prevention
Diabetes And Hypertension
Diabetes Mellitus, Type 2
Treatment
Control diet
Intermittent fasting
Clinical Study ID
NCT04607096
596/2020BO1
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 3or 5) or
- Subjects with diabetes mellitus type 2 (diagnosis < 1 year, HbA1c = 6,5 - 9 %, nomedical treatment, subphenotype SIDD or SIRD)
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-diabetic drugsor 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 active deviceslike automatic cardioverter defibrillators, cochlear implants, insulin pumps and nervestimulators, prosthetic heart valves etc.
- Persons with limited temperature sensation and / or elevated sensitivity to warming ofthe 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 up to 30 days prior to this study
- Refusal to get informed of unexpected detected pathological findings
Study Design
Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Control diet
Phase:
Study Start date:
April 08, 2021
Estimated Completion Date:
March 01, 2025
Connect with a study center
Charité Berlin - Department of Endocrinology and Metabolic Diseases
Berlin, 10117
GermanySite Not Available
Universtiy Hospital Carl Gustav Carus
Dresden, 01307
GermanySite Not Available
German Diabetes Center
Duesseldorf, 40225
GermanySite Not Available
Heidelberg University Hospital - Department of Endocrinology and Metabolism
Heidelberg, 69120
GermanySite Not Available
University Hospital Leipzig - Clinic for Endocrinology and Nephrology
Leipzig, 04103
GermanySite Not Available
University of Luebeck - Institute of Endocrinology and Diabetes
Luebeck, 23538
GermanySite Not Available
Technical University of Munich - Else Kroener-Fresenius-Center for Nutritional Medicine
Munich, 80992
GermanySite Not Available
University Hospital Tuebingen - Institute for Diabetes Research and Metabolic Diseases (IDM)
Tuebingen, 72076
GermanyActive - Recruiting
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