EUCTR2013-004316-22-GBActive, not recruitingPhase 1
INFLUENCE OF NITRATES ON BONE REMODELLING AND ENDOTHELIAL FUNCTION IN PATIENTS WITH TYPE 2 DIABETES MELLITUS - ENDOTHELIAL DYSFUNCTIO
Not provided0 sitesStarted: February 18, 2014Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Females and males aged between 40-75 years
- •A diagnosis of type 2 DM based on one of the following criteria (ADA - 2010):
- •-Fasting plasma glucose (FPG) >= 126 mg/dL (7.0 mmol/L) or
- •-2-h plasma glucose >= 200 mg/dl (11.1 mmol/L) during an OGTT or
- •-Classic symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose >= 200 mg/dL (11.1 mmol/L).
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
Exclusion Criteria
- •At screening, age below 40 years and above 75 years.
- •Pregnancy or lactation
- •Type 1 diabetes mellitus (patients with a history of ketoacidosis, age of onset of DM before 25 years of age, BMI <21 kg/m2 and use of insulin without a concomitant oral hypoglycemic agent)
- •Patients with uncontrolled hypertension (systolic blood pressure [SBP] > 160/90 mmHg) or hypotension (SBP of <=100 mm Hg or a diastolic BP of >= 110 mm Hg) at screening.
- •History of hypersensitivity to nitrates
- •History of raised intracranial pressure
- •History of cardiovascular disease (ischaemic heart disease, previous stroke and severe peripheral vascular disease [Ankle brachial pressure index - ABPI< 0.7])
- •History of general systemic illness including cardiac, hepatic or renal insufficiency
- •Patients with clinical nephropathy (24 hour protein > 0.5g or dipstix protein +) or renal failure (serum creatinine > 130 µmol/l).
- •History of migraine headaches
- •History of Paget’s disease and other metabolic bone disorders
- •History of coeliac or inflammatory bowel disease
- •History of multiple myeloma or cancer
- •History of nitrate use for cardiac conditions
- •History of glucocorticoid intake within the last 3 months
- •History of hormone replacement therapy in the last 12 months
- •History of treatment with SERM (selective estrogen receptor modulator)
- •History of treatment with thiazolidinedione
- •History of anticonvulsant use
- •History of past or current treatment for osteoporosis
- •History of bisphosphonate therapy within the last 3 years
Investigators
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