Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT02011620
Eligibility 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).
* Known history of type 2 diabetes mellitus on treatment
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) at screening.
* History of hypersensitivity to nitrates
* History of low blood pressure
* History of raised intracranial pressure (from cerebral haemorrhage or head trauma)
* History of cardiovascular disease (ischaemic heart disease, previous stroke and severe peripheral vascular disease \[Ankle brachial pressure index - ABPI\< 0.7\])
* History of acute circulatory failure (shock), circulatory collapse, cardiogenic shock
* History of hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/ mitral valve stenosis
* 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 anaemia
* History of closed angle glaucoma
* History of migraine headaches
* History of hypothyroidism
* History of hypothermia
* History of malnutrition
* 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 treatment with phosphodiesterase type-5 inhibitors
* History of foot ulcers
* History of active foot deformities e.g. Charcot foot
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT02011620
Study Brief:
Protocol Section:
NCT02011620