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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00686972
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Arm: 1
• Actual Duration (Months): 41
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This study is being conducted to evaluate changes in sugar, metabolism, heart function and changes in body composition as patients lose weight following bariatric surgery. The investigators will compare improvements of the above changes as a function of the four different types of bariatric surgery. The investigators believe the most beneficial and safest procedure will be the Roux-en-Y.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery	Drug: GLP-1	Phase 2

Detailed Description

The study will also examine the response of the pancreas (the insulin-producing organ) to a sugar load, as well as to a hormone called Glucagon Like Peptide 1 (GLP-1), which is released from your gut to maximally stimulate your pancreas. The release of this hormone increases when you eat food and it causes the pancreas to release more insulin than does sugar alone. Volunteers will have 22 visits over a two year period. Only people having Roux-en-Y gastric bypass surgery, gastric sleeve surgery, duodenal switch gastric surgery or lap-band/gastric banding surgery may join. Seventy volunteers will be recruited to take part in this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
• Actual Study Start Date: May 1, 2007
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GLP-1 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.	Drug: GLP-1; 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.; Other Names: Glucagon-like Peptide-1

Outcome Measures

Primary Outcome Measures

1. Insulin Secretion [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female volunteers 21-65 years.

• BMI > 40.

• Preoperative hematocrit level of at least 34% for women and 38% for men.

• Postoperative hematocrit level of at least 34% for women and 36% for men.

Exclusion Criteria:

• Volunteers whose hematocrit level does not meet the above criteria.

• Pregnant and or lactating females.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Dariush Elahi, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00686972
• Other Study ID Numbers: NA_00004876
• First Posted: May 30, 2008
• Last Update Posted: Jul 2, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Johns Hopkins University: Bariatric Surgery; Glucose Regulation; Cardiac Function; Body Composition
• Additional relevant MeSH terms: Weight Loss; Glucagon; Glucagon-Like Peptide 1

Study Results

Participant Flow

Arm/Group Title	Glucagon Like Peptide 1 -GLP-1
Arm/Group Description	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.
Period Title: Overall Study
STARTED	51
COMPLETED	0
NOT COMPLETED	51

Baseline Characteristics

Arm/Group Title	GLP-1
Arm/Group Description	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 Participants	51
Age, Customized (participants) [Number]
>=21 and <=65	51 100%
Sex: Female, Male (Count of Participants)
Female	43 84.3%
Male	8 15.7%
Region of Enrollment (participants) [Number]
United States	51 100%

Outcome Measures

1. Primary Outcome

Title	Insulin Secretion
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	GLP-1
Arm/Group Description	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.
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Adverse Event data, if collected, is unknown since no data are available.
Arm/Group Title	GLP-1
Arm/Group Description	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.
All Cause Mortality
	GLP-1
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	GLP-1
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	GLP-1
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.