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 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT02986659
Eligibility Criteria:
Inclusion Criteria:
* Age 65 - 79
Must meet criteria from one or more of the following groups:
Group 1 (Can have 1 or 2 of these, but not all 3)
* History of coronary artery disease (MI/heart attack, stroke, heart failure, or peripheral artery disease)
* Cancer, with no active treatment in the last year
* MCI (MoCA \>18\<26 -inclusive of 1 point if \<12 years of education Group 2
* Decline physical function (walking speed \< 1 m/s) Group 3 (Either or both)
* Abdominal obesity (\>88cm women, \>102cm men) AND hypertension (treated or resting blood pressure \>140/90
* Abdominal obesity (\>88cm women, \>102cm men) AND hyperlipidemia (treated or fasting total cholesterol \>240 English literacy Willing to provide informed consent
Exclusion Criteria:
* eGFR \<45
* Type 2 diabetes (HbA1c\>6.5) or type 1 diabetes
* Any tobacco or nicotine product use in the past year
* Low vitamin B12 Levels (\< 300 pg/mL)
* Self-reported severe difficulty or inability to walk 400m or climb 10 steps (from Q 2 and 19 on PAT-D)
* Self-reported difficulty or inability to perform basic ADL functions (from Q 10, 13, 14, 16 on PAT-D)
* Excessive alcohol use (\>14 drinks/week)
* Cancer requiring treatment in past year (except skin)
* Dementia - diagnosed and/or MoCA score \<18
* Parkinson's or other neurological disease
* Chronic liver disease or cirrhosis
* End stage renal disease or on dialysis
* Rheumatic conditions (Rheumatoid arthritis, lupus, and any other autoimmune disease the -PI deems them to be ineligible for)
* Thyroid problems the PI deems them to be ineligible for
* Gout
* Involved in another interventional study
* Hemoglobin \<8 or diagnosed with anemia
* Recent unintentional weight change (+/- 10 lbs. in the last 12 months)
* BMI \<18.5
* Likely to not follow the protocol
* PI deems unfit to participate
* Already taking Metformin or any other drug intended to treat diabetes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
79 Years
Study:
NCT02986659
Study Brief:
Protocol Section:
NCT02986659