ENDOTHELIAL DYSFUNCTION AND BONE REMODELLING MedDRA version: 16.1 Level: HLT Classification code 10067225 Term: Biochemical markers of bone metabolism System Organ Class: 100000004848 MedDRA version: 16.1 Level: PT Classification code 10048554 Term: Endothelial dysfunction System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: ISOSORBIDE MONONITRATE
Pharmaceutical Form: Tablet
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 160/90 mmHg) or hypotension (SBP 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 0.5g 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): IMPROVEMENT IN BONE MARKERS;Timepoint(s) of evaluation of this end point: 6 MONTHS | — |
Countries
United Kingdom
Outcome results
None listed