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Effects of Aerobic Exercise in Patients With Pre-diabetes

16 luglio 2014 aggiornato da: Sabyasachi Sen, MD, Baystate Medical Center

The Effect of Controlled Aerobic Exercise on Endothelial Dysfunction and Vascular Reactivity in Patients With Pre-diabetes: A Crossover Pilot Study

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

  • To refine a non-invasive test for endothelial dysfunction. The investigators will examine the flow response to sheer-stress induced by the relief of pressure exerted with a blood pressure cuff on the brachial artery, measuring flow responses with Doppler. This is a measure of local nitric oxide production from endothelial cells which is known to be impaired in diabetics, normal in non-diabetics, but unknown in prediabetics.
  • To measure in the same individuals indicators of glucose metabolism abnormalities including fasting blood glucose, HbA1C, insulin sensitivity by homeostasis model assessment-estimated insulin resistance (HOMA-IR) and insulin levels.
  • To measure Endothelial Progenitor Cell (EPC) count, viability, gene expression of key genes such as endothelial nitric oxide synthase (eNOS), von-Willebrand's Factor (vWF) and adhesion molecules such platelet-endothelial cell adhesion molecule-1 (PECAM-1 or CD31), cadherin such as Vascular-Endothelial cadherin (VE-cadherin)or CD (cell surface marker)-144, growth factors such as vascular-endothelial growth factor (VEGF)and Insulin like growth factor (IGF-1)in the EPCs from pre-diabetes subjects pre and post exercise.
  • Correlate the glucose metabolism abnormalities with potential causative factors of endothelial dysfunction by studying EPC functions such as migration and tube formation and susceptibility to apoptosis in moderate hyperglycemia. Apoptosis assay will be done by Flow Cytometry analysis using Annexin V- Propidium-iodide dye.
  • Subjects will be randomized to the intervention (structured exercise) or continuation of their usual life style (non-exercise, sedentary)group.

In both arms of the study, subjects will be encouraged to adhere to the standard dietary advice that all pre-diabetic patients receive as part of their standards of care, irrespective of design arm they will be in.

The investigators expect exercise to improve flow-mediated vasodilatation, EPC colony count and function, along with better key gene expressions noted by Real Time-qualitative polymerase chain reaction (PCR).

  • Assess the effects of the intervention comparing them to the findings in each individual, in a paired manner.
  • After a washout period, individuals will be crossed over to see whether the effects of the intervention are reversed and to demonstrate that the difference between controls and intervention subjects was due to the aerobic exercise intervention, and not due to random differences

Tipo di studio

Interventistico

Iscrizione (Anticipato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Springfield, Massachusetts, Stati Uniti, 01199
        • Baystate Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

    1. Smoking
    2. Hypertension (B/P > 140/90 or on antihypertensives)
    3. HDL < 40mg/dl
    4. 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
  • CA
  • Alcoholism
  • Women who are pregnant or intending to become pregnant
  • Oral or Injectable antidiabetic medication
  • Post menopausal women on hormone replacement
  • Any steroid medication (oral, inhaled, injected or nasal)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Prediabetes with exercise
150 minutes of moderate exercise per week
Comportamentale: Exercise
150 minutes of moderate exercise per week
Altro: Prediabetes without exercise
Pre-study activity level (i.e. no exercise)
Comportamentale: Without exercise
Pre-study activity level (i.e. no exercise)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Measures of Endothelial Function by studying number, function and gene expression of endothelial progenitor cells (identified as CD34+ cells)
Lasso di tempo: 16 weeks per patient
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Measures of Vacular Reactivity
Lasso di tempo: 16 weeks
A) Measure Brachial reactivity through shear-stress using flow mediated dilatation (FMD) B). Measure Arterial Stiffness measure pre and post exercise. C) Measure Carotid Intima Media Thickness will be measured at each time point
16 weeks

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Measures of Insulin Sensitivity by measuring inflammatory molecules as a surrogate of insulin resistance
Lasso di tempo: 16 weeks

We will measure:

A. plasma measurements of cytokines, including C - reactive protein, E-selectin, IL-6, IL-10, thrombin, leptin, adiponectin, fasting glucose, fasting insulin and fasting lipid profile from subjects are expected to reflect endothelial inflammation.

B. Insulin sensitivity will be evaluated at baseline and weeks 6, 10 and16 using the HOMA ratio, calculated from individual serum measures (fasting glucose* insulin/405) C.Adiposity will be measured at baseline and at weeks 6, 10, and 16 using the Tanita Body Composition Analyzer scale, measured as percentage body fat D. Resting energy expenditure as measures of indirect calorimetry for basal metabolic rate measures (BMR).
16 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Baystate Medical Center

Investigatori

  • Investigatore principale: Sabyasachi Sen, MD, PhD, Baystate Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2010

Completamento primario (Effettivo)

1 maggio 2013

Completamento dello studio (Effettivo)

1 maggio 2013

Date di iscrizione allo studio

Primo inviato

9 maggio 2013

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2013

Primo Inserito (Stima)

23 maggio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

17 luglio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 luglio 2014

Ultimo verificato

1 luglio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB132171

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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