Modulation of Sympathetic Nerve Activity By Pioglitazone In Type 2 Diabetes Mellitus
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- EUCTR2004-003822-80-GB
- Lead Sponsor
- The Leeds Teaching Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 16
Known type 2 diabetic
Aged 18-75 years old
Caucasian
Patients eligible for Pioglitazone
In according to NICE guidelines(March 2001) and manufacturer’s guidelines
Type 2 diabetes with inadequate glycaemic control HBa1C>7.8%
In Combination with metformin only
Absence of exclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Hypertension
On insulin therapy
Absence of sinus rhythm
Left ventricular hypertrophy On ECG and or echocardiography (LIFE study Criteria)
Taking drugs known to interfere with the parameters measured
Malignancy
Poly neuropathy
Alcoholism
Previous myocardial infarction or CVA 6 months ago
Chronic renal failure
Chronic liver disease
Familial adenomatosis polyposis coli
Overt psychiatric illness
Contraindications to Pioglitazone (severe Heart Failure, breast feeding, pregnancy)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To see if Pioglitazone improves the sympathetic nerve hyperactivity observed in type 2 diabetes ;Secondary Objective: ;Primary end point(s): Statistically significant reduction in sympathetic activity in those treated with Pioglitazone
- Secondary Outcome Measures
Name Time Method