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Trial Outcomes & Findings for Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery (NCT NCT00178633)

NCT ID: NCT00178633

Last Updated: 2020-11-23

Results Overview

Change in weight. Negative values represent weight loss.

Recruitment status

COMPLETED

Target enrollment

43 participants

Primary outcome timeframe

0 to 9 months

Results posted on

2020-11-23

Participant Flow

IRB Approved to begin recruitment, 5.20.2004. Enrollment ended June 2006. All patients recruited from University of Texas Houston, Bariatric Surgery Center.

Participant milestones

Participant milestones
Measure
Bariatric Surgery
Overall Study
STARTED
43
Overall Study
COMPLETED
37
Overall Study
NOT COMPLETED
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Bariatric Surgery
Overall Study
Lost to Follow-up
6

Baseline Characteristics

Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Bariatric Surgery
n=43 Participants
Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
Age, Continuous
45 years
STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male
Female
37 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
Region of Enrollment
United States
43 participants
n=5 Participants

PRIMARY outcome

Timeframe: 0 to 9 months

Population: broken out into 0-3months and 3-9months below

Change in weight. Negative values represent weight loss.

Outcome measures

Outcome measures
Measure
Bariatric Surgery
n=37 Participants
Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
Change in Weight
0-3 Months Post Procedure
-21.5 kg
95% Confidence Interval 18.1 • Interval -25.0 to -18.1
Change in Weight
3-9 Months Post Procedure
-16.4 kg
Interval -20.1 to -12.8

SECONDARY outcome

Timeframe: 0-9 Months

Population: broken out into 0-3months and 3-9months below

Change in glucose. Negative values represent a decrease in glucose levels.

Outcome measures

Outcome measures
Measure
Bariatric Surgery
n=37 Participants
Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
Change in Glucose
0-3 Months
-19.1 mg/dL
Interval -33.2 to -5.0
Change in Glucose
3-9 Months
-2.0 mg/dL
Interval -11.2 to 7.2

SECONDARY outcome

Timeframe: 0-9 Months

Population: Analysis broken down into 0-3 months and 3-9 months

Change in tissue doppler diastolic velocity. Negative values indicate a decrease in tissue doppler diastolic velocity.

Outcome measures

Outcome measures
Measure
Bariatric Surgery
n=27 Participants
Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
Change in Tissue Doppler Diastolic Velocity
0-3 Months
0.4 cm/s
Interval -0.06 to 1.3
Change in Tissue Doppler Diastolic Velocity
3-9 Months
-0.4 cm/s
Interval -1.1 to 0.4

SECONDARY outcome

Timeframe: 0-9 Months

Population: broken out into 0-3months and 3-9months below

Change in left ventricular mass, or myocardium, as measured in centimeters using echocardiography. Negative values represent a decrease in ventricular mass.

Outcome measures

Outcome measures
Measure
Bariatric Surgery
n=37 Participants
Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
Change in Left Ventricular Mass
0-3 Month
-3.0 g/m^2.7
Interval -6.1 to 0.1
Change in Left Ventricular Mass
3-9 Month
-6.3 g/m^2.7
Interval -10.2 to -2.4

Adverse Events

Bariatric Surgery, Follow up at 9 Months

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Bariatric Surgery, Follow up at 2 Years

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

Heinrich Taegtmeyer, MD, DPhil, Principal Investigator

University of Texas Medical School at Houston

Phone: 713 500-6569

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place