Effects of Aerobic Exercise in Patients With Pre-diabetes

NCT01860599 | Completed

• 1 other identifier: IRB132171
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prediabetes

Keywords

prediabetes; EPC's; vascular reactivity

Outcome Measures

Primary Outcomes (1)

• Measures of Endothelial Function by studying number, function and gene expression of endothelial progenitor cells (identified as CD34+ cells)

  A. Number of viable CD34 +ve cells at Day-0 and viability assay. B. Colony Formation count assay at Day-5, pre and post exercise. C. We will test CD34+ cell migration, adhesion and tube formation properties. D. Gene expression in CD34+ cells of critical endothelial function and inflammatory genes will be measured: eNOS, vWF and PECAM1, VE-cadherin, VEGF-A, Superoxide dismutase (SOD)-1, 2 and 3, Catalase, Interleukin (IL)-6, Tumor Necrosis Factor (TNF alpha), P53, P21, PUMA, Bcl2 \[Apoptosis genes\] will also be noted

  16 weeks per patient

Secondary Outcomes (1)

• Measures of Vacular Reactivity

  16 weeks

Other Outcomes (1)

• Measures of Insulin Sensitivity by measuring inflammatory molecules as a surrogate of insulin resistance

  16 weeks

Study Arms (2)

Prediabetes with exercise

OTHER

150 minutes of moderate exercise per week

Behavioral: Exercise

Prediabetes without exercise

OTHER

Pre-study activity level (i.e. no exercise)

Behavioral: Without exercise

Interventions

Exercise BEHAVIORAL

150 minutes of moderate exercise per week

Prediabetes with exercise

Without exercise BEHAVIORAL

Pre-study activity level (i.e. no exercise)

Prediabetes without exercise

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sabyasachi Sen, MD, PhD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Endocrinology

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 23, 2013
• Study Start: March 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

US (1)