The Effects of Renal Denervation on Insulin Sensitivity
|ClinicalTrials.gov Identifier: NCT01631370|
Recruitment Status : Unknown
Verified December 2013 by Ulla Kampmann Opstrup, University of Aarhus.
Recruitment status was: Enrolling by invitation
First Posted : June 29, 2012
Last Update Posted : December 24, 2013
|Condition or disease||Intervention/treatment|
|Treatment Resistant Essential Hypertension Insulin Resistance||Procedure: Renal denervation|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Renal Sympathetic Denervation on Insulin Sensitivity in Patients With Resistant Essential Hypertension|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: Renal denervation
The patients will be examined prior to renal denervation and 6 months after. Thus the patients are their own controls.
Procedure: Renal denervation
The patients are examined prior to and 6 months after renal denervation. On the day of examination the patients will have blood samples taken and the hyperinsulinemic euglycemic clamp and muscle and adipose tissue biopsies will be performed.
- Insulin sensitivity expressed as an M-value [ Time Frame: 4 hours ]To assess insulin sensitivity the hyperinsulinemic euglycemic clamp is used. The patients are given 0.8 mU/kg/min insulin as an infusion for 2 hours and the blood glucose is clamped at 5 mmol/l. For assessment of endogenous glucose production (EGP) during the glucose clamps, a tracer (3-3 H glucose) is added to the glucose infusion. The patients will be examined by the hyperinsulinemic euglycemic clamp prior to the renal denervation and 6 months after.
- Insulin signaling [ Time Frame: 6 months ]Two biopsies from the lateral vastus muscle and two biopsies from the abdominal subcutaneous adipose tissue are obtained under local anesthesia. Biopsies are taken at baseline and during the clamp. Protein expression involved in the insulin signalling cascade is assessed using standard western blotting techniques.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631370
|Medical Research Laboratories, Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Per Løgstrup, MD Dr Sci||Department of Endocrinology and Internal Medicine, Aarhus University Hospital|