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 @ 9:36 PM
Ignite Modification Date:
2025-12-24 @ 9:36 PM
NCT ID:
NCT01170832
Eligibility Criteria:
Inclusion/Exclusion Criteria:
* Male or female between the ages 18-65, with type 1 diabetes of 5-10 years duration who are free of complications and age-and-sex-matched healthy control volunteers.
* Hemoglobin A1c greater than 7 %. (For Type 1 diabetics)
* If you are a woman of childbearing potential you must agree to use an acceptable birth control method throughout the duration of the study. The methods of birth control that you can use are: Oral contraceptives (birth control pill), IUD or a barrier method (e.g. diaphragm or condom with spermicide).
* You should have no history of any cardiovascular disease including any form of coronary artery disease, congestive heart failure, known arrhythmias (irregular heart beats), valvular disease or high blood pressure.
* If you have any pacemaker or ICD, if you have any metallic foreign body such as surgical implants or clips or foreign bodies in the eye or orbits, wearing medication patches containing foil, or any other metal in the body or if you are claustrophobic you cannot participate in this study.
* You should be free of any diabetic complications (e.g. nephropathy or kidney damage, retinopathy or eye damage), have no history of previous kidney, pancreas or cardiac transplantation, any other severe chronic illness that has neuropathy (numbness, burning or tingling) and/or neurologic disease as a recognized complication (e.g. Parkinson's disease, epilepsy), or any other serious medical conditions that may shorten life span (e.g. disabling stroke, Chronic Obstructive Pulmonary Disease).
* You should be free of any malignancy other than basal cell skin cancer.
* No history of alcohol abuse.
* You should not use any agents or drugs that interfere with the imaging techniques described below.
* You must be able to cooperate with the test protocols that are described below and be willing to sign this consent form.
Inclusion for Control group:
* BMI \<30
* If female, must not be pregnant or nursing
* Normal blood pressure
* Normal labs-(glucose and lipids)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01170832
Study Brief:
Protocol Section:
NCT01170832