The Effects of Renal Denervation on Insulin Sensitivity

NCT01631370 | Completed DMC

• 1 other identifier: UKOM20110071
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Renal sympathetic nerves contribute to development of hypertension. Sympathetic overactivity also induces insulin resistance and it could therefore be assumed that a renal denervation might improve insulin sensitivity. Studies have shown that glucose metabolism is improved in patients with treatment resistant essential hypertension both 1 and 3 months after renal denervation compared to a control group with treatment resistant essential hypertension. Fasting glucose, insulin and C-peptide decreased significantly as did insulin resistance assessed by HOMA-IR. The investigators wish to investigate the effect of renal denervation on insulin sensitivity using the gold standard - the hyperinsulinemic euglycemic clamp and to investigate the degree of insulin resistance in muscle, liver and adipose tissue.

Conditions

Treatment Resistant Essential Hypertension; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity expressed as an M-value

  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.

  4 hours

Secondary Outcomes (1)

• Insulin signaling

  6 months

Study Arms (1)

Renal denervation

EXPERIMENTAL

The patients will be examined prior to renal denervation and 6 months after. Thus the patients are their own controls.

Procedure: Renal denervation

Interventions

Renal denervation PROCEDURE

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.

Renal denervation

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic

You may not qualify if:

• Diabetes
• Pregnancy
• Non compliance
• Heart Failure (NYHA 3-4)
• LV ejection fraction \< 50 %
• Renal insufficiency (eGFR\<30)
• Unstable coronary heart disease
• Coronary intervention within 6 months
• Myocardial infarction within 6 months
• Claudication
• Orthostatic syncope within 6 months
• Secondary Hypertension
• Permanent atrial fibrillation
• Significant Heart Valve Disease
• Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Medical Research Laboratories, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Per Løgstrup, MD Dr Sci

  Department of Endocrinology and Internal Medicine, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: June 29, 2012
• Study Start: June 1, 2012
• Primary Completion: March 30, 2015
• Study Completion: March 3, 2016
• Last Updated: May 2, 2018

Record last verified: 2015-04

Locations

DK (1)