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 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT01932866
Eligibility Criteria:
Inclusion Criteria:
* Men and women of all ethnic groups
* ≥30 -75 years of age
* Pre-diabetic defined as follows: fasting plasma glucose (FPG) 100-125mg/dL, HbA1c 5.7% to 6.4%.
* Body Mass Index ≥ 25 kg/m2
* Tricare beneficiary
Exclusion Criteria:
Diagnosis of type 1 or type 2 diabetes mellitus (defined as FPG ≥126 mg/dl on two different occasions or random blood sugar ≥200) If fasting glucose \>= 126 only once, a second lab does not need to be arranged in an attempt to diagnose diabetes. It is acceptable for the patient to proceed in the trial. Also, Tethys lab results (e.g., fasting glucose and A1C) should not be used to make decisions about including or excluding patients in the trial. Only Air Force lab results should be used to make this determination.
* Active duty military members
* Patients with untreated hypothyroidism or previously diagnosed Cushing's syndrome
* Subjects previously treated with metformin or thiazolidinediones in the previous 12 months
* Psychological or physical disabilities deemed likely to interfere with participation in the study
* Patients currently using weight-loss medications or medications known to affect body weight (i.e. chronic corticosteroid use)
* Major medical conditions that prevent participation in the Group Lifestyle Balance Prevention Program (i.e. severe cardiovascular or cerebrovascular disease, severe renal or liver dysfunction, etc.)
* Concurrent participation in a different weight loss program
* Previous bariatric surgery
* Unwilling to agree with the study assignments or provide informed consent
* Participation in any other research project that would interfere with this protocol
* Unable to read and write English
* Pregnant or nursing patients
* Female patients unwilling to undergo a pregnancy test or report possible pregnancy promptly and unwilling to take precautions to avoid pregnancy if potentially fertile during the study course
Discontinuation Criteria:
* Consent is withdrawn
* Death occurs
* A woman becomes pregnant
* Severe impairment of manual dexterity, vision, or intellectual function
* They become lost to follow-up because of a move or transfer outside of the geographic area
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT01932866
Study Brief:
Protocol Section:
NCT01932866