The effect of the increase of free fatty acids on functional lipodystrophy in the severe insulin-resistant subtype of diabetes (FFAIR study) - FFAIR

niversitätsklinikum Heidelberg0 个研究点目标入组 24 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

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•Age between = 18 and = 75 years, BMI between 22 and 45 kg/m2, patients 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 value, pathological fasting glucose above 126 mg/dl, pathological spontaneous glucose of = 200 mg/dl at least twice) and fulfillment of the following criteria: Diagnosis = 1 year, No therapy with insulin, glitazones or sulfonylurea, HbA1c = 6.5 - 9%, Assignment of diabetes as SIRD or cluster 5* (comparable to diabetes subphenotype SIRD), Ability to consent, Understanding of study explanations and instructions.

•General exclusion criteria:
•- Type 1 diabetes or secondary forms of diabetes (ADA criteria type 3 B-H).
•- Patients on insulin therapy or lipid-lowering medications (statins, fibrates)
•- Hyperlipidemia (triglycerides >150mg/dl, cholesterol > 200 mg/dl)
•- Current pregnancy
•- Acute infections/fever
•- Immunosuppressive therapy
•- Known severe psychiatric disorders requiring treatment (e.g. Personality disorders, schizophrenia, depression)
•- Known dependence on alcohol or other drugs
•- Severe heart, kidney or liver disease
•- NYHA stage IV
•- Known non-diabetic liver disease (e.g., PBC, PSC, Wilson's disease, 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 study
•- Known anemia or bone marrow disorders
•Exclusion criteria for clamp study:
•- History of thrombosis or peripheral pulmonary artery embolism
•- Routine clinical chemistry laboratory values: = 80% of the lower
•Reference value: ferritin, iron, leukocytes, Hb, Hkt, erythrocytes,
•Platelets, (residual) blood alcohol detection [‰]

发起方

niversitätsklinikum Heidelberg