Trial Outcomes & Findings for The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition (NCT NCT00686972)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

2 years

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Glucagon Like Peptide 1 -GLP-1 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period. GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Overall Study STARTED	51
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Glucagon Like Peptide 1 -GLP-1 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period. GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Overall Study P.I, Left institution. Study terminated	51

Baseline Characteristics

The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GLP-1 n=51 Participants 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period. GLP-1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Age, Customized >=21 and <=65	51 participants n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.

Outcome measures

Outcome data not reported

Adverse Events

GLP-1

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

Johns Hopkins University Clinical Trials Program

Johns Hopkins University School of Medicine

Phone: 410-550-6484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place