Resolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients. (LGCP)

March 11, 2012 updated by: Kuldeep Singh, Singh, Kuldeep, M.D., P.A.

Laparoscopic Greater Curvature Plication for Weight Loss and Resolution of Diabetes and Other Comorbidities.

Various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal reflux. Laparoscopic gastric plication or laparoscopic greater curvature placation ( LGCP) has recently been done as an alternative to the other restrictive procedures. But the short and long term safety and efficacy outcomes of LGCP is not well documented in current literature. American society of metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be considered investigational at this time and should be performed under a study protocol with third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.

The objective of this study will be to demonstrate feasibility , short term and long term safety and efficacy of LGCP . This will be done by achieving gastric restriction by infolding of stomach and thereby achieving good weight loss .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Since the acceptance of surgical procedures to achieve a sustainable weight loss, many different procedures has been tried with variable success. Among them , various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal reflux. Currently, laparoscopic adjustable gastric band ( LAGB) and sleeve gastrectomy are being used with variable acceptance and success. Laparoscopic gastric plication or laparoscopic greater curvature plication ( LGCP) has recently been done as an alternative to the other restrictive procedures. But the short and long term safety and efficacy outcomes of LGCP is not well documented in current literature. American society of metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be considered investigational at this time and should be performed under a study protocol with third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.

A prospective nonrandomized study at Cleveland clinic suggested that a reduction in gastric capacity can be achieved by way of plication of stomach and thereby achieving encouraging weight loss. We intend to study this procedure as an alternative to LAGB or sleeve gastrectomy for carefully selected patients. The objective of this study will be to demonstrate feasibility , short term and long term safety and efficacy of LGCP . This will be done by achieving gastric restriction by infolding of stomach and thereby achieving good weight loss . The subjects will be followed up post operatively to observe the effect on the comorbidities along with sustained weight loss. The inclusion and exclusion criteria , target population, duration of subject participation and primary endpoints will be defined and all the data will be recorded per protocol.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Recruiting
        • Saint Agnes Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Isam Hamdallah, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is willing to give consent and comply with evaluation and treatment schedule;
  2. 18 to 65 years of age (inclusive);

  3. Have a BMI > 27 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. These conditions may include but are not be limited to -

    • Hyperlipidemia
    • Type 2 diabetes
    • Mild obstructive sleep apnea
    • Hypertension
    • Osteoarthritis of the hip or knee
  4. Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective procedure that would affect body weight for the duration of the trial;
  5. HbA1C < 11%
  6. For subjects who have Type 2 diabetes, the anti-diabetic medication regimen is no more complex than oral metformin plus one oral sulfonylurea plus once daily insulin injection.
  7. Ability to self pay for the procedure and follow up.

Exclusion Criteria:

  1. Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
  2. Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
  3. Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
  4. Any condition which precludes compliance with the study;
  5. History or presence of pre-existing autoimmune connective tissue disease
  6. Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.
  7. Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts. Any condition which places the subject at undue risk for the procedure (surgeon's discretion).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent excess weight loss
Time Frame: 3 years
The percent excess weight loss at 3-years from the time of surgery. The primary analysis will include all available data at the 3-year follow-up.
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resolution of comorbidities
Time Frame: 3 years
The following comorbidities will be assessed at regular intervals: diabetes, dyslipidemia, liver dysfunction, and hypertension. Measures will include glycosylated hemoglobin, triglycerides, low-density lipoprotein, high-density lipoprotein, serum albumin, liver transaminases, systolic and diastolic blood pressures.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Singh, Kuldeep, M.D., P.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kuldeep Singh, MD, Kuldeep Singh, MDPA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RPN 2011-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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