- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00753766
Multifactorial Pre-operative Intervention in Diabetes Mellitus
Multifactorial Pre-Operative Intervention in Diabetes Mellitus
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Patients with diabetes that require hospitalization are at increased risk for morbidity and mortality, especially when undergoing surgery. There is some evidence that intensive glucose management during hospitalization may improve outcomes. However, no studies have evaluated intensive diabetes treatment before hospitalization.
Preliminary data from patients having vascular surgery show that those with diabetes have longer hospital stays, more frequent wound infections, and are more likely to require a return to the operating room when compared to patients without diabetes. In particular, insulin-treated patients have even greater peri-operative complications than non-insulin treated patients with diabetes. However, these data also suggest that a clinical trial to test the hypothesis that pre-operative intensive management has significant impact on peri-operative complications would require a very large number of participants to have adequate power.
Thus, our objective is to conduct a pilot and feasibility study to determine whether an intervention that involves intensive pre-operative diabetes management can be successfully implemented and to assess whether trends for benefit are observed. The results of this trial will support the conduct of a definitive study that tests the effectiveness of such an intervention in a larger sample of patients.
This is a randomized, parallel group clinical trial in insulin-treated patients with diabetes mellitus who have been scheduled for elective vascular surgery. We will randomize 46 participants diabetes mellitus: insulin-treated with HbA1c 7.5% or treated with oral agents with an elevated HbA1c who are scheduled for vascular surgery and in whom a 6 week pre-operative delay poses no substantial medical risks, as determined by the staff surgeon. We will exclude individuals with markedly elevated HbA1c or blood pressure; those with recently manifest cardiovascular disease, and those unable to attend regularly scheduled follow-up visits during the pre-operative period.
Participants will be randomized to either continue with usual care or participate in a multifactorial intervention conducted over a 6-week period. During the intervention period, participants will meet with a care manager and/or endocrinologist on at least 3 occasions and have telephone follow-up between these visits. They will receive instruction on lifestyle modifications; measure glucose and blood pressure at home (including the use of a continuous glucose monitoring device on 2 occasions), and receive care management to optimize glucose, blood pressure, and lipid lowering, as appropriate.
The primary outcome measure is the percent of screened participants that are eligible and choose participation Secondary end points will include: participant adherence with the study protocol, change from baseline in A1c and fructosamine, occurrence of wound infections in the 30-day peri-operative period, a composite of death from cardiovascular causes, non-fatal myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, nonfatal stroke, or amputation as a result of peripheral ischemia; length of hospital stay; and rate of return to the operating room.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosis of diabetes mellitus
- A1c 7.5%,
- Scheduled elective vascular surgery that may be safely deferred for 6 weeks
- Surgeon's approval to participate
Exclusion Criteria:
- Hemoglobin A1c >14% (This criterion was included since, once identified, such a patient warrants improved glucose control and can not be ethically entered into a trial where there is a 50% chance of being assigned to usual care)
- Myocardial infarction in prior 6 months
- Cerebrovascular disease in prior 6 months
- Active cancer requiring ongoing treatment
- Severe psychiatric disease limiting ability to comply with protocol
- Unable to attend follow up appointments
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Solita cura
Gruppo di controllo
|
|
Sperimentale: Multifactorial Intervention
Mulitfactorial intervention - addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Percent of Screened Participants That Are Eligible and Choose Participation
Lasso di tempo: 6 weeks
|
6 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Percentage of Participants With Full Adherence to the Study Protocol (i.e. Attending Study Visits, CGMS Studies)
Lasso di tempo: 6 weeks
|
6 weeks
|
|
Percentage of Participants Not Completing the Protocol Due to the Need for Urgent Surgery and/or Treatment-related Complications
Lasso di tempo: 6 weeks
|
6 weeks
|
|
Change in A1c From Baseline to Pre-admission (A1c is the Standard Parameter to Assess Chronic Glucose Control])
Lasso di tempo: 6 weeks
|
A1c measured at two time points - baseline and 6 weeks later (pre-admission).
This parameter is the difference between those two time points.
|
6 weeks
|
Number of Participants With Occurrence of Wound Infection in the 30 Day Post-operative Period
Lasso di tempo: 30 days
|
30 days
|
|
Length of Hospital Stay
Lasso di tempo: 6 weeks
|
6 weeks
|
|
Number of Participants Who Experience a Composite of Death From Cardiovascular Cause, Non-fatal Myocardial Infarction, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention, Nonfatal Stroke, or Amputation as a Result of Peripheral Ischemia
Lasso di tempo: 6 weeks
|
6 weeks
|
|
Percentage of Participants Who Need to Return to the Operating Room
Lasso di tempo: 6 weeks
|
6 weeks
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Paul R. Conlin, MD, VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CLIN-004-04F
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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