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:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT03082859
Eligibility Criteria:
Inclusion Criteria:
* 18-60 year-old men who have been diagnosed with Type 2 diabetes by a clinician at least 3 months prior to the start of the study according to standard criteria.
* Able and willing to safely comply with all study procedures.
* Able to provide written informed consent whilst acknowledging their freedom to withdraw at any point during the study.
* Inactive or moderately physically active according to the International Physical Activity Questionnaire.
Exclusion Criteria:
* Aged \< 18 years or \> 60 years
* Female
* Insulin therapy
* Use of more than two antidiabetic drugs
* Use of βblockers
* Use of inhaled steroids (e.g. for asthma)
* Any cardiovascular condition with the exception of well-controlled uncomplicated hypertension (systolic \>160 mmHg and/or \>90mmHg after at least 5 min of seated rest), which is treated with no more than two drugs (either an ACE, ARB, calcium channel blocker, or diuretic)
* Cerebrovascular disease including previous stroke or aneurysm
* History of exercise-induced asthma
* History of Type 1 diabetes mellitus or a history of ketoacidosis
* History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug or chemical-induced, and post organ transplant)
* Any prior history of malignancy with the exception of: basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has been recurrence free for 5 years, other malignancies (regardless of site) that have been recurrence free for 10 years.
* History of respiratory disease including pulmonary hypertension or chronic obstructive pulmonary disease
* History of musculoskeletal or neurological disorders
* Active inflammatory bowel disease
* History of renal disease
* Other metabolic diseases, including hyper/ hypo parathyroidism, hyper/hypo thyroidism, and Cushing's disease.
* BMI\>35 kg/m2
* Uncontrolled hypertension (systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>90 mm Hg after at least a 5 minute seated rest at the screening visit).
* A clinically significant resting and/or exercise ECG abnormality at the pre-screening visit which in the opinion of the cardiovascular physiologist exposes the participant to risk by take part in the main trial. In line with The Society for Cardiological Science \& Technology recommendations for exercise testing, this includes:
* Central nervous system symptoms (e.g. ataxia, dizziness, or near syncope)
* Signs of poor perfusion (cyanosis or pallor)
* Any detection of arrhythmias
* Rapid ST elevation with or without pain
* Systolic blood pressures \>230mmHg
* \>2mm ST elevation with symptoms
* \>3mm ST depression without symptoms
* 'Yes' to any questions on a standard physical activity readiness questionnaire (PARQ)
* Classification as highly physically active on the International Physical Activity Questionnaire (IPAQ)
* Current participation in another research study
* Inability to fully understand the verbal and written descriptions of the study in English, and the instructions provided during the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03082859
Study Brief:
Protocol Section:
NCT03082859