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Clinical Trials/NL-OMON46844
NL-OMON46844
Completed
Not Applicable

Role of endothelial surface layer in regulating the sodium balance and extracellular fluid volume - SALT-2 study

Academisch Medisch Centrum0 sites24 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

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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