Pancreatic beta-cell dysfunction REStorEd by Rosiglitazone and Valsartan Effects: a 52-week randomised controlled factorial study in subjects with impaired fasting glucose and/or impaired glucose tolerance

Completed

• Conditions: Impaired glucose metabolism; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN42786336
• Lead Sponsor: VU University Medical Center (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Male and female subjects (aged 35 to 70 years)
2. Impaired Fasting Glucose (IFG): fasting plasma glucose 6.1 or higher and less than 7.0 mmol/l, or fasting plasma glucose 5.6 or higher and less than 7.0 mmol/l) and a family history of Diabetes Mellitus type two (DM2) (i.e. first and second degree [i.e. grandparents] relatives)
3. Impaired Glucose Tolerance (IGT): two hour plasma glucose during 75 g oral glucose tolerance test 7.8-11.1 mmol/l

Exclusion Criteria

Drug use:
1. Current use of Angiotensin-Converting Enzyme Inhibitors (ACE-I), Angiotensin Receptor Blockers (ARB) and/or Thiazolidinediones (TZDs) and inability to discontinue these drugs
2. Known hypersensitivity to any of the study drugs
3. Prior use of blood glucose lowering medications except during pregnancy
4. Use of systemic glucocorticoids or niacin

Cardiovascular co-morbidities:
1. Ejection fraction known to be less than 40% or congestive heart failure, or existing clinical Cardio-Vascular (CV) disease:
a. previous Myocardial Infarction [MI] or stroke
b. angina with either more than 50% stenosis in more than or equal to two major coronary arteries, or ST depression of more than or equal to 2 mm, or a positive nuclear test, or previous coronary angioplasty, stent or bypass
c. previous limb bypass or vessel angioplasty or angiographic evidence of more than 50% stenosis, or intermittent claudication with an ankle/arm pressure less than or equal to 0.8
2. Uncontrolled hypertension requiring ACE-I or ARB

Other Criteria:
1. History of diabetes (except gestational DM) or on anti-diabetic medication
2. Renal or Hepatic Disease:
a. renal artery stenosis
b. creatinine clearance less than 40 ml/min or serum creatinine 200 umol/l or higher
c. clinical proteinuria (one or above, positive proteinuria on dipstick or 300 mg and above albuminuria/day, in the absence of urine)
d. measured Alanine Transferase (ALT) 2.5 or more times the upper limit of normal
e. active liver disease including jaundice, chronic hepatitis, previous liver transplant
3. Major illness with life expectancy of less than five years or that may interfere with participation
4. Use of another experimental drug
5. Pregnant or unwilling to use reliable contraception (fertile women will have a pregnancy test prior to randomisation)
6. Major psychiatric disorder
7. Diseases and medications that affect glucose tolerance (e.g. pheochromocytoma, Cushing?s syndrome, acromegaly, steroid-dependent asthma, protease inhibitors, anti-psychotics)
8. Unwillingness to be randomised or sign informed consent)
9. Known uncontrolled substance abuse
10. Inability to understand study information and/or communicate with clinic staff

Study & Design

• Study Type: Interventional
• Study Design: Not specified