NL-OMON46844
Completed
Not Applicable
Role of endothelial surface layer in regulating the sodium balance and extracellular fluid volume - SALT-2 study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 24
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diabetic patients (n\<\=12\)
- •\- Male between 18 and 40 years old
- •\- Known with Diabetes Mellitus \- type 1
- •\- With or without microalbuminuria defined as:
- •o either albuminuria 20\-200 mg/L in a morning urine sample
- •o or albuminuria 30\-300 mg/24 hrs collected in a 24\-hours urine collection
- •o or albumin\-to\-creatinin ratio 2,5\-25 mg/mmol in a morning urine sample.
- •\- Stable renal function (creatine clearance \> 60 ml/min and \< 6 ml/min per year decline) with or without stable therapy with RAAS inhibiting agents
- •\- HbA1c levels between 6\.0 and 10\.0% (42\-86 mmol/mol) during the 6 months preceding the study
- •\- Multiple injections of insulin a day
Exclusion Criteria
- •\- An office blood pressure \>140/90 mmHg
- •\- A body mass index \> 30 kg/m2
- •\- A major illness in the past 3 months or any significant chronic medical illness that the Investigator would deem unfavourable for enrolment, including chronic inflammatory diseases
- •\- A history of any type of malignancy within the past 5 years with the exception of successfully treated basal cell cancer of the skin
- •\- A history of any renal disease
- •\- A history of cardiovascular disease (in the past 6 months) defined as documented coronary artery disease including myocardial infarction, (un\-)stable angina pectoris or acute coronary syndrome, precutenaous transluminal coronary angioplasty, coronary artery bypass grafting, cerebrovascular disease including ischemic and hemorrhagic stroke or a subarachnodial bleeding, or peripheral artery disease including aortic aneurysmata
- •\- A history of coagulation disorders
- •\- A history of primary hyperlipoproteinemias
- •\- A history of hypersensitivity or allergy to iodium or to shell fish
- •\- A history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, THC, methamphetamine)
Outcomes
Primary Outcomes
Not specified
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