Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery

February 6, 2023 updated by: Naji Abumrad, Vanderbilt University Medical Center
The purpose of this study is to determine if the altered nutrient exposure to the GI tract after bariatric surgery reveals a negative incretin effect of ghrelin.

Study Overview

Status

Status

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

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.

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.
70

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.
  • Phase 1

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
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

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

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI ≥ 35 kg/m2
  • Age 21-65 years
  • Weight ≤ 200 kg

Exclusion Criteria:

  • Type 2 or Type 1 diabetes
  • Medications that alter insulin sensitivity or carbohydrate metabolism
  • Positive pregnancy test
  • Known history of intestinal diseases including, but not limited to, inflammatory bowel disease (e.g. Chronic Ulcerative Colitis, Crohn's disease, celiac sprue)
  • Prior gastric or intestinal surgery or pancreas resection
  • History of cardiovascular disease, including but not limited to: myocardial infarction, angioplasty, arrhythmia, uncontrolled hypertension
  • History of chronic kidney disease or renal insufficiency; creatinine > 1.8 mg/dl.
  • History of chronic liver disease, including but not limited to: cirrhosis, hepatitis, portal hypertension; AST and/or ALT > 2x the upper limit of normal.
  • Abnormal ECG

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
EXPERIMENTAL: Vertical Sleeve Gastrectomy (VSG) NJ/PO
Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively.
Procedure: Oral Glucose Tolerance Test (OGTT)
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
Other Names:
  • OGTT
Drug: Human Ghrelin
Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
Other Names:
  • Ghrelin
Drug: Saline
Saline Infusion will be administered by IV at two of the four study visits in conjunction with the OGTT to serve as a placebo comparator for the human ghrelin infusions.
Other Names:
  • NaCl, sodium chloride
EXPERIMENTAL: Roux-en-Y Gastric Bypass (RYGB) NJ/PO
Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively.
Procedure: Oral Glucose Tolerance Test (OGTT)
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
Other Names:
  • OGTT
Drug: Human Ghrelin
Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
Other Names:
  • Ghrelin
Drug: Saline
Saline Infusion will be administered by IV at two of the four study visits in conjunction with the OGTT to serve as a placebo comparator for the human ghrelin infusions.
Other Names:
  • NaCl, sodium chloride
EXPERIMENTAL: Vertical Sleeve Gastrectomy (VSG) PO/PO
Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed.
Procedure: Oral Glucose Tolerance Test (OGTT)
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
Other Names:
  • OGTT
Drug: Human Ghrelin
Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
Other Names:
  • Ghrelin
Drug: Saline
Saline Infusion will be administered by IV at two of the four study visits in conjunction with the OGTT to serve as a placebo comparator for the human ghrelin infusions.
Other Names:
  • NaCl, sodium chloride
EXPERIMENTAL: Roux-en-Y Gastric Bypass (RYGB) PO/PO
Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed.
Procedure: Oral Glucose Tolerance Test (OGTT)
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
Other Names:
  • OGTT
Drug: Human Ghrelin
Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
Other Names:
  • Ghrelin
Drug: Saline
Saline Infusion will be administered by IV at two of the four study visits in conjunction with the OGTT to serve as a placebo comparator for the human ghrelin infusions.
Other Names:
  • NaCl, sodium chloride

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
Change in plasma glucose levels with ghrelin versus saline.
Time Frame: 1 month (before and after surgery)
The objective for this protocol is to determine if ghrelin infusion worsens glucose tolerance during jejunal administration of glucose and if the response is difference after bariatric surgery (RYGB or VSG).
1 month (before and after surgery)

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
Time Frame
Plasma insulin levels
Time Frame: 1 month (before and after surgery)
1 month (before and after surgery)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma Levels of GLP-1
Time Frame: 1 month (before and after surgery)
Metabolic panel to include plasma levels of GLP-1
1 month (before and after surgery)
Plasma Levels of GIP
Time Frame: 1 month (before and after surgery)
Metabolic panel to include plasma levels of GIP
1 month (before and after surgery)
Plasma Levels of leptin
Time Frame: 1 month (before and after surgery)
Metabolic panel to include plasma levels of leptin
1 month (before and after surgery)
Plasma Levels of pancreatic polypeptide
Time Frame: 1 month (before and after surgery)
Metabolic panel to include plasma levels of pancreatic polypeptide
1 month (before and after surgery)
Plasma Levels of Peptide YY (PYY)
Time Frame: 1 month (before and after surgery)
Metabolic panel to include plasma levels of PYY
1 month (before and after surgery)
Plasma Levels of C-Peptide
Time Frame: 1 month (before and after surgery)
Metabolic panel to include plasma levels of C-Peptide
1 month (before and after surgery)
Plasma Levels of glucagon
Time Frame: 1 month (before and after surgery)
Metabolic panel to include plasma levels of glucagon
1 month (before and after surgery)
Plasma Levels of Cholecystokinin (CCK)
Time Frame: 1 month (before and after surgery)
1 month (before and after surgery)
Plasma Levels of Cholecystokinin Adrenocorticotropic Hormone (ACTH)
Time Frame: 1 month (before and after surgery)
1 month (before and after surgery)
Plasma Levels of Human Growth Hormone (HGH)
Time Frame: 1 month (before and after surgery)
1 month (before and after surgery)
Plasma Levels of Cortisol
Time Frame: 1 month (before and after surgery)
1 month (before and after surgery)
Plasma Levels of insulin-like growth factor 1 (IGF-1)
Time Frame: 1 month (before and after surgery)
1 month (before and after surgery)
Acyl and desacyl ghrelin
Time Frame: 1 month (before and after surgery)
1 month (before and after surgery)
Plasma Levels of Bile Acids
Time Frame: 1 month (before and after surgery)
1 month (before and after surgery)
Plasma Levels of Free Fatty Acids (FFAs)
Time Frame: 1 month (before and after surgery)
1 month (before and after surgery)
Plasma Levels of Triglycerides (TG)
Time Frame: 1 month (before and after surgery)
1 month (before and after surgery)
Performance on Visual Analog Scale for Hunger
Time Frame: 1 month (before and after surgery)
1 month (before and after surgery)

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.
Vanderbilt University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.
September 1, 2016

Primary Completion (ACTUAL)

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.
August 21, 2019

Study Completion (ACTUAL)

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.
January 30, 2023

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).
September 22, 2016

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.
October 31, 2016

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.
November 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

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.
February 8, 2023

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.
February 6, 2023

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.
February 1, 2023

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.
  • 111237-Protocol II
  • R01DK091748 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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