ObesityPhase 1NCT02953587
Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery
A Phase 1 study testing Oral Glucose Tolerance Test (OGTT), Human Ghrelin and Saline in people with Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Oral Glucose Tolerance Test (OGTT), Human Ghrelin and Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 30 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 35 kg/m2
- Age 21-65 years
- Weight ≤ 200 kg
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
- Conditions
- Obesity
- Being tested
- Oral Glucose Tolerance Test (OGTT), Human Ghrelin, Saline
- Keywords
- Obesity, Bariatric Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance Test (OGTT)Procedure or surgery
Also called OGTT
Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
Human GhrelinDrug
Also called Ghrelin
Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
SalineDrug
Also called NaCl, sodium chloride
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.
| Study group | Role | What they receive |
|---|---|---|
| Vertical Sleeve Gastrectomy (VSG) NJ/PO | Experimental | 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. Receives: Procedure: Oral Glucose Tolerance Test (OGTT); Drug: Human Ghrelin; Drug: Saline |
| Roux-en-Y Gastric Bypass (RYGB) NJ/PO | Experimental | 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. Receives: Procedure: Oral Glucose Tolerance Test (OGTT); Drug: Human Ghrelin; Drug: Saline |
| Vertical Sleeve Gastrectomy (VSG) PO/PO | Experimental | 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. Receives: Procedure: Oral Glucose Tolerance Test (OGTT); Drug: Human Ghrelin; Drug: Saline |
| Roux-en-Y Gastric Bypass (RYGB) PO/PO | Experimental | 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. Receives: Procedure: Oral Glucose Tolerance Test (OGTT); Drug: Human Ghrelin; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma glucose levels with ghrelin versus saline.
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).
Measured: 1 month (before and after surgery)
Secondary outcomes (1)
Plasma insulin levels
Measured: 1 month (before and after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion21 Aug 2019
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naji Abumrad, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953587
- Sponsor's protocol ID
- 111237-Protocol II
- Other IDs
- R01DK091748
- Status last verified
- Feb 2023
- First submitted
- 22 Sep 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ghrelin on Glucose Metabolism After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02953587
- Acronym / sponsor ID
- 111237-Protocol II
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric Surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2016
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vertical Sleeve Gastrectomy (VSG) NJ/PO | Experimental | Procedure: Oral Glucose Tolerance Test (OGTT), Drug: Human Ghrelin, Drug: SalinePatients 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. |
| Roux-en-Y Gastric Bypass (RYGB) NJ/PO | Experimental | Procedure: Oral Glucose Tolerance Test (OGTT), Drug: Human Ghrelin, Drug: SalinePatients 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. |
| Vertical Sleeve Gastrectomy (VSG) PO/PO | Experimental | Procedure: Oral Glucose Tolerance Test (OGTT), Drug: Human Ghrelin, Drug: SalinePatients 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. |
| Roux-en-Y Gastric Bypass (RYGB) PO/PO | Experimental | Procedure: Oral Glucose Tolerance Test (OGTT), Drug: Human Ghrelin, Drug: SalinePatients 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI ≥ 35 kg/m2
- Age 21-65 years
- Weight ≤ 200 kg
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Glucose Tolerance Test (OGTT)Also: OGTTSubjects will have glucose administered enterally and blood will be drawn to measure its kinetics. | Procedure or surgery | Roux-en-Y Gastric Bypass (RYGB) NJ/PO, Roux-en-Y Gastric Bypass (RYGB) PO/PO, Vertical Sleeve Gastrectomy (VSG) NJ/PO, Vertical Sleeve Gastrectomy (VSG) PO/PO |
| Human GhrelinAlso: GhrelinHuman ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT. | Drug | Roux-en-Y Gastric Bypass (RYGB) NJ/PO, Roux-en-Y Gastric Bypass (RYGB) PO/PO, Vertical Sleeve Gastrectomy (VSG) NJ/PO, Vertical Sleeve Gastrectomy (VSG) PO/PO |
| SalineAlso: NaCl, sodium chlorideSaline 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. | Drug | Roux-en-Y Gastric Bypass (RYGB) NJ/PO, Roux-en-Y Gastric Bypass (RYGB) PO/PO, Vertical Sleeve Gastrectomy (VSG) NJ/PO, Vertical Sleeve Gastrectomy (VSG) PO/PO |
Primary outcome
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 secondary outcome
Plasma insulin levels
Time frame: 1 month (before and after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral Glucose Tolerance Test (OGTT), Human Ghrelin and Saline in people with Obesity, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma glucose levels with ghrelin versus saline. (time frame: 1 month (before and after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.