Effects of Aerobic Exercise in Patients With Pre-diabetes

Completed · Not applicable

Conditions studied: Prediabetes

In brief

It is well known that diabetes and excessive or high blood sugars causes blood vessel and blood cell damage. It is also possible, then, that people with pre-diabetes may also start to have blood vessel and blood cell damage as the blood sugars rise from the normal range into the diabetic range. In addition to looking at potential damage, the question is whether or not this damage improves with exercise. This study aims to look at blood vessel and blood cells in three different ways by 1) looking at how the blood vessel responds to "sheer force" (a blood pressure cuff pumped up and then released after a few minutes). This is done by ultrasound. 2) By looking at blood tests such as blood sugar, cholesterol, and inflammation and 3) By looking at certain blood cells in the lab, how long they live and the number of cells left after a certain number of days, and again, if this improves with exercise.

Key facts

Study ID

NCT01860599

Run by

Baystate Medical Center

People needed

30

Starts

2010-03-01

Expected to finish

2013-05-01

Last updated by the study team

2014-07-17

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prediabetic
• Impaired fasting glucose (100-125mg/dl)
• Impaired glucose tolerance (2' post between 140-199mg/dl)
• HbA1C 5.7-6.4 mg/d (inclusive)
• Exercise Naive
• BMI between 20-39.9
• Nutritional Counseling prior to participation with CDE/RD
• Willing to wear activity monitor
• Willing to keep a dietary log

You may not qualify if…

• Pace maker or other implanted device that might have interference with Tanita scale
• Any contraindication to moderate exercise
• Previous coronary disease or cerebrovascular event active or clinically significant coronary vascular disease, or peripheral vascular disease
• Diabetes
• Uncontrolled hypertension (SBP > 140 or DBP > 90 on 3 separate occasions) ACE's or ARB's
• Premature familial CAD (Father < 55years____ Mother <65years)
• HDL < 40mg/dl
• Triglycerides >400mg/dl
• Any new lipid lowering medication started in the past 6 months
• Framingham Risk Score two or more
• Smoking
• Hypertension (B/P > 140/90 or on antihypertensives)
• HDL < 40mg/dl
• Age men >45years or women >55years
• Low hematocrit ( or hemoglobinopathies that may impair exercise tolerance) or abnormal CBC
• Uncontrolled hypo/hyperthyroidism
• Active smoking
• Liver disease ( alt or AST> 2.5's UNL)
• Moderate or Severe Kidney disease, current or history
• Pancreatitis, current or history
• Any medication started in the last 3 months
• Active non healing wounds
• Recent Surgery in the last 3 months
• Anti-inflammatory disease, current or history
• Regular use of anti-inflammatory drugs

Where it is running

• Baystate Medical Center — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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