Multifactorial Pre-operative Intervention in Diabetes Mellitus

NCT00753766 | Terminated Results DMC

• 1 other identifier: CLIN-004-04F
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to advance the quality of care among inpatients with diabetes in the VHA. When patients with diabetes are admitted to the hospital, there is a greater chance that they will have a complication that lengthens their stay in the hospital. We are testing whether managing their diabetes before admission makes a difference in occurrence of in-hospital complications.

Conditions

Diabetes Mellitus; Surgical Procedure, Unspecified

Keywords

A1c; Blood Glucose Management; Blood Pressure; Case Management; Diabetes Mellitus; Intervention study; Multifactorial; Peri-operative complications; Pre-operative

Outcome Measures

Primary Outcomes (1)

• Percent of Screened Participants That Are Eligible and Choose Participation

  6 weeks

Secondary Outcomes (7)

• Percentage of Participants With Full Adherence to the Study Protocol (i.e. Attending Study Visits, CGMS Studies)

  6 weeks

• Percentage of Participants Not Completing the Protocol Due to the Need for Urgent Surgery and/or Treatment-related Complications

  6 weeks

• Change in A1c From Baseline to Pre-admission (A1c is the Standard Parameter to Assess Chronic Glucose Control])

  6 weeks

• Number of Participants With Occurrence of Wound Infection in the 30 Day Post-operative Period

  30 days

• Length of Hospital Stay

  6 weeks

Study Arms (2)

Multifactorial Intervention

EXPERIMENTAL

Mulitfactorial intervention - addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.

Other: Multifactorial Intervention

Usual care

NO INTERVENTION

Control group

Interventions

Multifactorial Intervention OTHER

Multifactorial Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of diabetes mellitus
• A1c 7.5%,
• Scheduled elective vascular surgery that may be safely deferred for 6 weeks
• Surgeon's approval to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Paul R. Conlin, M.D.
• Organization: VA Boston Healthcare System

paul.conlin@va.gov

8572035111

Study Officials

• Paul R. Conlin, MD

  VA Boston Healthcare System West Roxbury Campus, West Roxbury, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 17, 2008
• Study Start: October 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: September 1, 2008
• Last Updated: February 11, 2019
• Results First Posted: September 26, 2014

Record last verified: 2019-02