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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT01353066
Eligibility Criteria:
Inclusion Criteria:
* Age 35 to 65 years at eligibility visit.
* Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least he six months prior to enrollment, and HbA 1c \> 7.0 %.
* Current treatment for T2DM consisting of multiple doses of insulin with/without hypoglycemic agents or hypoglycemic agents plus basal insulin.
* Optimization of diabetes medical treatment prior to inclusion in the study would have been performed based on best medical practices.
* Body Mass Index (BMI)\> 30.0 kg/m2 and \<34.9 kg/m2 at eligibility visit.
* Willingness to accept random assignment to either treatment group.
* Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.
* Willingness to comply with the follow-up protocol and successful completion of the run-in.
* Written informed consent.
Exclusion Criteria:
* Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
* Current evidence of congestive heart failure (grade II or IV), angina pectoris, symptomatic peripheral vascular disease or advanced cardiovascular disease.
* History of severe hypoglycemic episodes associated with medical treatment of type 2 DM
* Cardiac stress test indicating that surgery would not be safe
* Pulmonary embolus or thrombophlebitis in the past six months.
* Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
* Significant anemia or history of coagulopathy.
* Serum creatinine \>1.5 mg/dl.
* Serum total bilirubin or alkaline phosphatase greater than the upper limit of normal, or ALT greater than twice the upper limit of normal.
* History of previous surgery contraindicating gastric bypass at the criteria of the surgical team.
* Gastric or duodenal ulcer in the past six months.
* History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).
* Previous organ transplantation.
* Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
* Currently pregnant or nursing, or planning to become pregnant in the next two years.
* History of alcohol or drug dependency (excluding caffeine and nicotine) in the past five years
* Active psychosocial or psychiatric problem that is likely to interferer with adherence to the protocol.
* Score of 17 or higher on the CES-D (depression scale).
* Current participation in a conflicting research protocol.
* Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
* 12-lead EKG indicating that surgery or intensive medical treatment would not be safe.
* Diagnosed with diabetes more than 15 years ago.
* Positive GAD antibodies
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT01353066
Study Brief:
Protocol Section:
NCT01353066