Clinical trial NCT02312843: Piedmont Aging, Cognition & Exercise Study-2
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Prediabetes
Keywords: Mild Cognitive Impairment
Cognitive disorders
Prediabetes
Exercise
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2014-12-09
Enrollment: 33
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in cognitive performance from baseline following 6 month of high or low intensity exercise regimen
timeFrame: 2 assessments, one before and one after 6 months of exercise
Secondary outcomes:
measure: Change from baseline in blood sugar concentration and cerebrospinal fluid glucose measures during an oral glucose tolerance test following 6 months of high or low intensity exercise
timeFrame: 3 Oral glucose tolerance tests over a 6 month period; 2 lumbar punctures, one before and one after the 6 month exercise regimen
Other outcomes:
measure: Change from baseline in brain network connectivity using brain imaging
timeFrame: 2 brain scans over a 6 month period, one before and one after the 6 month exercise regimen
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Laura D. Baker, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: