Piedmont Aging, Cognition & Exercise Study-2



Status:Completed
Conditions:Cognitive Studies, Endocrine, Diabetes
Therapuetic Areas:Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:50 - 89
Updated:8/17/2018
Start Date:March 2013
End Date:April 2017

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A Randomized Controlled Trial to Examine the Effects of Aerobic Exercise on Cognition and Aging-related Biomarkers for Adults With Prediabetes and Mild Cognitive Impairment

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 this exercise on certain proteins and hormones in body fluids, and on
brain structure and function using magnetic resonance imaging (MRI). Recent studies indicate
that exercise improves memory and thinking abilities for adults with mild memory loss OR
pre-diabetes. This study examines the effects of exercise on people with mild memory loss AND
pre-diabetes.


Inclusion Criteria:

- 50 years or older

- Mild memory concerns

- In good health

- Not taking diabetes medications

- Not currently exercising

Exclusion Criteria:

- 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
We found this trial at
1
site
Winston-Salem, North Carolina 27157
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mi
from
Winston-Salem, NC
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