diabetes mellitus type 2, lipodystrophy E11
Conditions
Interventions
Group 1: Patients with SIRD. Administration of a fat infusion with a fat emulsion vs. administration of a control infusion with a fat component.
Group 2: Age-, weight-, and sex-matched healthy partici
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, 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.
Exclusion criteria
Exclusion criteria: 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 [‰]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mitochondrial function measured by mitochondrial respiration in skeletal muscle and subcutaneous fat tissue. A hyperinsulinemic-euglycemic clamp will be performed with two different treatments: 1) administration of a fat infusion with a fat emulsion as used to feed patients in intensive care units and 2) administration of a control infusion with a fat building block (glycerol). The order of the clamp examinations is random. The second clamp examination occurs approximately 4-6 weeks after the first clamp examination. Biopsy collection is performed at each clamp examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| The accumulation of RM and AGEs in skeletal muscle and SWF. The detoxification of RM (including measurement of glyoxalase and aldo-keto reductase activity). A hyperinsulinemic-euglycemic clamp will be performed with two different treatments: 1) administration of a fat infusion with a fat emulsion as used to feed patients in intensive care units and 2) administration of a control infusion with a fat building block (glycerol). The order of the clamp examinations is random. The second clamp examination occurs approximately 4-6 weeks after the first clamp examination. Biopsy collection is performed at each clamp examination. | — |
Countries
Germany
Contacts
Public ContactAlba Sulaj
Universitätsklinikum Heidelberg
Outcome results
None listed