THE EFFECT OF NITRATES ON BONE STRENGTH AND BLOOD FLOW THROUGH SMALL BLOOD VESSELS

Phase 1

• Conditions: ENDOTHELIAL DYSFUNCTION AND BONE REMODELLING; MedDRA version: 16.1Level: HLTClassification code 10067225Term: Biochemical markers of bone metabolismSystem Organ Class: 100000004848; MedDRA version: 16.1Level: PTClassification code 10048554Term: Endothelial dysfunctionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2013-004316-22-GB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-18
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the role of nitrates in improving microvascular blood flow;Secondary Objective: To determine whether nitrates can cause an increase in bone formation markers and reduction in bone resorption markers.;Primary end point(s): IMPROVEMENT IN MICROVASCULAR BLOOD FLOW;Timepoint(s) of evaluation of this end point: 6 MONTHS

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): IMPROVEMENT IN BONE MARKERS;Timepoint(s) of evaluation of this end point: 6 MONTHS