Trial Outcomes & Findings for Multifactorial Pre-operative Intervention in Diabetes Mellitus (NCT NCT00753766)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

6 weeks

Results posted on

2019-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Multifactorial Intervention Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.	Usual Care Control group
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Multifactorial Intervention Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.	Usual Care Control group
Overall Study Physician Decision	1	0

Baseline Characteristics

Multifactorial Pre-operative Intervention in Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multifactorial Intervention n=1 Participants Mulitfactorial intervention - addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.	Usual Care Control group	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.

Outcome measures

Outcome measures
Measure	Multifactorial Intervention n=1 Participants Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.	Usual Care Control group
Percent of Screened Participants That Are Eligible and Choose Participation	100 percentage of potential participants	—

SECONDARY outcome

Timeframe: 6 weeks

Population: The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.

Outcome measures

Outcome measures
Measure	Multifactorial Intervention n=1 Participants Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.	Usual Care Control group
Percentage of Participants With Full Adherence to the Study Protocol (i.e. Attending Study Visits, CGMS Studies)	0 percent of participants	—

SECONDARY outcome

Timeframe: 6 weeks

Population: The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.

Outcome measures

Outcome measures
Measure	Multifactorial Intervention n=1 Participants Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.	Usual Care Control group
Percentage of Participants Not Completing the Protocol Due to the Need for Urgent Surgery and/or Treatment-related Complications	100 percent of participants	—

SECONDARY outcome

Timeframe: 6 weeks

Population: The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and data for this parameter were not collected. There were -0- participants enrolled in the Usual Care group.

A1c measured at two time points - baseline and 6 weeks later (pre-admission). This parameter is the difference between those two time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.

Outcome measures

Outcome measures
Measure	Multifactorial Intervention n=1 Participants Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.	Usual Care Control group
Number of Participants With Occurrence of Wound Infection in the 30 Day Post-operative Period	0 Participants	—

SECONDARY outcome

Timeframe: 6 weeks

Population: The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.

Outcome measures

Outcome measures
Measure	Multifactorial Intervention n=1 Participants Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.	Usual Care Control group
Length of Hospital Stay	6 days	—

SECONDARY outcome

Timeframe: 6 weeks

Population: The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.

Outcome measures

Outcome measures
Measure	Multifactorial Intervention n=1 Participants Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.	Usual Care Control group
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	0 Participants	—

SECONDARY outcome

Timeframe: 6 weeks

Population: The one participant who entered the trial was assigned to the Multifactorial Intervention group but was withdrawn from the study for safety reasons, and very limited data could be analyzed. There were -0- participants enrolled in the Usual Care group.

Outcome measures

Outcome measures
Measure	Multifactorial Intervention n=1 Participants Mulitfactorial intervention - included addressing glucose, blood pressure, lipids, smoking, nutrition and exercise.	Usual Care Control group
Percentage of Participants Who Need to Return to the Operating Room	0 percent of participants	—

Adverse Events

Multifactorial Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul R. Conlin, M.D.

VA Boston Healthcare System

Phone: 8572035111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place