ObesityPhase 1NCT01474785
RYGB and the Gastric Adipose Axis
A Phase 1 study testing human ghrelin, very low calorie diet and Hyperinsulinemic/Euglycemic Clamp in people with Obesity, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to determine if interruption in gastric-adipose tissue axis signaling contributes to early improvements in oxidative stress, insulin sensitivity, and inflammation, and to determine if interruption of the stomach in RYGB results in reduction of plasma acylated ghrelin (AG) and in an altered… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- human ghrelin, very low calorie diet and Hyperinsulinemic/Euglycemic Clamp
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- BMI ≥ 35 kg/m^2
- Scheduled for bariatric surgery
- Considering bariatric surgery
- Waiting for insurance approval for bariatric surgery
- Currently not considering bariatric surgery, but otherwise eligible
- Enrollment in medical weight loss program
Who cannot join
- Smoking >7 cigarettes per day
- Precious malabsorptive or restrictive intestinal surgery
- Pregnant or breastfeeding
- Recent history of neoplasia (5<years ago)
- Malabsorptive syndromes
- Inflammatory intestinal disease
- Established organ disfunction
- Allergy to acetaminophen
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 34232
About this study
Official title: RYGB Improves Metabolism by Interrupting the Gastric Adipose Tissue Axis
The purpose of this study is to determine if interruption in gastric-adipose tissue axis signaling contributes to early improvements in oxidative stress, insulin sensitivity, and inflammation, and to determine if interruption of the stomach in RYGB results in reduction of plasma acylated ghrelin (AG) and in an altered acylated ghrelin:unacylated ghrelin (AG:UAG) ratio which may contribute to decreased oxidative stress and improved insulin sensitivity.
- Conditions
- Obesity
- Being tested
- human ghrelin, very low calorie diet, Hyperinsulinemic/Euglycemic Clamp
- Keywords
- Obesity, Bariatric surgery, Nashville, Tennessee
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human ghrelinDrug
0.5-1 pmol/kg.min of human ghrelin administered by IV two times
very low calorie dietOther
standard very low calorie diet that is prescribed for all RYGB patients after their operation
Hyperinsulinemic/Euglycemic ClampProcedure or surgery
Insulin and glucose infusions to measure glucose kinetics.
| Study group | Role | What they receive |
|---|---|---|
| RYGB | Experimental | Roux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively. Receives: Drug: human ghrelin; Procedure: Hyperinsulinemic/Euglycemic Clamp |
| VSG | Experimental | Vertical sleeve gastrectomy (VSG) subjects to undergo hyperinsulinemic-euglycemic clamp pre-operatively and post-operatively. Receives: Procedure: Hyperinsulinemic/Euglycemic Clamp |
| Low Calorie Diet | Experimental | Subjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet. Receives: Other: very low calorie diet; Procedure: Hyperinsulinemic/Euglycemic Clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in glucose disposal rate
Glucose disposal rate is a sensitive laboratory procedure for determining how your body uses sugar (called insulin sensitivity).
Measured: baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naji Abumrad, Vanderbilt University
- Investigators
- Naji Abumrad, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474785
- Sponsor's protocol ID
- #111237
- Other IDs
- R01DK091748
- Status last verified
- Jan 2018
- First submitted
- 15 Nov 2011
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Flynn CR, Tamboli RA, Antoun J, Sidani RM, Williams B, Spann MD, English WJ, Welch EB, Sundaresan S, Abumrad NN. Caloric Restriction and Weight Loss Are Primary Factors in the Early Tissue-Specific Metabolic Changes After Bariatric Surgery. Diabetes Care. 2022 Aug 1;45(8):1914-1916. doi: 10.2337/dc22-0069.
PubMed 35724307
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RYGB Improves Metabolism by Interrupting the Gastric Adipose Tissue Axis
- ClinicalTrials.gov ID
- NCT01474785
- Acronym / sponsor ID
- #111237
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Nashville, Tennessee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Nov 2011 (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 interruption in gastric-adipose tissue axis signaling contributes to early improvements in oxidative stress, insulin sensitivity, and inflammation, and to determine if interruption of the stomach in RYGB results in reduction of plasma acylated ghrelin (AG) and in an altered acylated ghrelin:unacylated ghrelin (AG:UAG) ratio which may contribute to decreased oxidative stress and improved insulin sensitivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RYGB | Experimental | Drug: human ghrelin, Procedure: Hyperinsulinemic/Euglycemic ClampRoux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively. |
| VSG | Experimental | Procedure: Hyperinsulinemic/Euglycemic ClampVertical sleeve gastrectomy (VSG) subjects to undergo hyperinsulinemic-euglycemic clamp pre-operatively and post-operatively. |
| Low Calorie Diet | Experimental | Other: very low calorie diet, Procedure: Hyperinsulinemic/Euglycemic ClampSubjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-65 years
- BMI ≥ 35 kg/m^2
- Scheduled for bariatric surgery
- Considering bariatric surgery
- Waiting for insurance approval for bariatric surgery
Key exclusion criteria (8 listed)
- Smoking >7 cigarettes per day
- Precious malabsorptive or restrictive intestinal surgery
- Pregnant or breastfeeding
- Recent history of neoplasia (5<years ago)
- Malabsorptive syndromes
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 |
|---|---|---|
| human ghrelin0.5-1 pmol/kg.min of human ghrelin administered by IV two times | Drug | RYGB |
| very low calorie dietstandard very low calorie diet that is prescribed for all RYGB patients after their operation | Other | Low Calorie Diet |
| Hyperinsulinemic/Euglycemic ClampInsulin and glucose infusions to measure glucose kinetics. | Procedure or surgery | Low Calorie Diet, RYGB, VSG |
Primary outcome
change in glucose disposal rate
Time frame: baseline and 1 week
Glucose disposal rate is a sensitive laboratory procedure for determining how your body uses sugar (called insulin sensitivity).
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 21 May 2018.
- Derived from this study: PubMed 35724307Flynn CR, Tamboli RA, Antoun J, Sidani RM, Williams B, Spann MD, English WJ, Welch EB, Sundaresan S, Abumrad NN. Caloric Restriction and Weight Loss Are Primary Factors in the Early Tissue-Specific Metabolic Changes After Bariatric Surgery. Diabetes Care. 2022 Aug 1;45(8):1914-1916. doi: 10.2337/dc22-0069.
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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.
Naji Abumrad, MD principal investigator
Vanderbilt University Medical Center
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 human ghrelin, very low calorie diet and Hyperinsulinemic/Euglycemic Clamp in people with Obesity, run by Vanderbilt University 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 7 inclusion and 8 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 21 May 2018. 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 glucose disposal rate (time frame: baseline and 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01474785, which also lists 1 linked publication.
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 21 May 2018.