Status:
COMPLETED
Piedmont Aging, Cognition & Exercise Study-2
Lead Sponsor:
Wake Forest University
Collaborating Sponsors:
American Diabetes Association
Conditions:
Mild Cognitive Impairment
Prediabetes
Eligibility:
All Genders
50-89 years
Phase:
NA
Brief Summary
The purpose of this research study is to examine the effects of high and low intensity exercise for those with mild memory loss and pre-diabetes. The investigators will also examine the effects of thi...
Eligibility Criteria
Inclusion
- 50 years or older
- Mild memory concerns
- In good health
- Not taking diabetes medications
- Not currently exercising
Exclusion
- Significant neurologic disease that might affect cognition, such as AD, stroke, Parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness \> 30 min or with permanent neurologic sequelae;
- Significant medical illness or organ failure, such as:
- Liver disease: history of hepatitis or hepatic failure
- Significant elevations in liver function tests: lab values more than 2.5 times the upper limit of normal
- Kidney disease known history of kidney failure.
- Uncontrolled hypertension
- Cardiovascular disease, defined as: any acute cardiovascular abnormality, such as new or unstable angina, uncontrolled irregular heart beat (treated a-fib and occasional PVC's are OK) or symptomatic heart failure, acute shortness of breath for any reason, or clinically significant edema, is an exclusion. History in the last year of myocardial infarction, angina, coronary artery angioplasty, bypass grafting, pacemaker insertion, STENT placement, postural hypotension, transient ischemic attack, or carotid artery surgery.
- Chronic lung disease, such as: COPD/emphysema
- Hemoglobin A1c levels that fall outside the range of 5.7-6.4%; If 2-h OGTT glucose values 220 mg/dL and hemoglobin A1c levels meet inclusion criteria (5.7-6.4%), then PCP written indication that no pharmacologic intervention for type 2 diabetes is needed at present will be required for continued study participation.
- Current use of anti-psychotic, anti-convulsant, anxiolytic, or sedative medication;
- Current use of any cognition-enhancing medication, including experimental medications within the past 60 days;
- Current or previous use of hypoglycemic agents or insulin (except during pregnacy); diabetics previously on oral agents but have been off of them for \> 1 year are ok pending PI and study physician approval.
- Musculoskeletal impairment sufficient to interfere with study participation
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02312843
Start Date
March 1 2013
End Date
April 1 2017
Last Update
August 15 2018
Active Locations (1)
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1
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157