Type II Diabetes Mellitus and and microvascular complications
Conditions
Interventions
On the study day, a non-diagnostic dose CT scan will be performed to optimally position the individual patient for the dynamic PET scan (e.g. with kidney, aorta and part of the liver inside the field
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: - Type 2 diabetes - urinary albumin:creatinine ratio (UACR) >3.4 mg/mmol - Age ≥ 40 years <70 years - Written informed consent
Exclusion criteria
Exclusion criteria: - Pregnant women and women of child-bearing potential who are not using reliable contraception - Use of an ACE inhibitor or angiotensine receptor blocker - Cardiovascular disease: myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) 160/ 100 mmHg) - Active malignancy - History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension) - Participation in any clinical investigation within 3 months prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations. - Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing - History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening. - Lithium use - Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: o Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection o Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months o Pancreatic injury or pancreatitis within the last six months o Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are dynamic PET data and images and radiation count measurement, and free plasma concentrations of telmisartan. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are Glomerular Filtration Rate and Urine Albumin:Creatinine Ratio. | — |
Contacts
Public ContactH. Lambers Heerspink
University Medical Center Groningen
Outcome results
None listed