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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT02725502
Eligibility Criteria:
Inclusion Criteria:
* Male or female adult, aged 15 to 30 years
* Duration of type 1 Diabetes Mellitus for 6 months or more, as established by medical history
* Current treatment with multiple injections of insulin for at least 3 months prior to screening visit; and using the same insulin during the last 1 month
* HbA1c \< 8%
* Body mass index (BMI) \< 25 kg/mt2
* Euthyroid patient. If thyroid dysfunction is present then thyroid function test (TFT) should be normal at the time of study ( with medication)
Exclusion Criteria:
* On pramlintide, metformin, GLP1 agonist or DPP4 inhibitor. If taking this drugs then stop them 2 wk prior to study.
* On prokinetics \& proton pump inhibitor (PPI). If taking this drugs then stop them 2 wk prior to study
* Creatinine of \>1.5 mg/dl or a calculated creatinin clearance of \<50 ml/min or overt proteinuria.
* Fasting blood glucose (FBG) \< 72 or \> 180 in the day of mixed meal test (MMT)
* Pregnant
* Seriously ill patients
* Presence of gastroparesis ( if history is suggestive of autonomic neuropathy or gastroparesis then gastric emptying study to be done to rule it out)
* Type 1 Diabetes Mellitus for less than 6 months duration
* Presence of celiac disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
30 Years
Study:
NCT02725502
Study Brief:
Protocol Section:
NCT02725502