Type II Diabetes MellitusNCT00887302
Metabolomics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy
An observational study of Type II Diabetes Mellitus and Obesity, run by East Carolina University at 1 site in United States.
Trial summary
This study is an investigation of the "metabolomics of RYGB with gastrostomy." Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Type II Diabetes Mellitus, Obesity
- What is being tested?
- Gastric Band, Gastric Sleeve and Gastrostomy Tube
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2009to 12 Oct 2012
- Phase
- Observational
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Obese caucasian females between the ages of 18-60 who have had bariatric surgery.
Who may be able to join
- Female
- 18-60 years of age
- BMI of 35-65
- Willing to comply with study requirements and long term follow-up
- Capable of understanding the requirements and consequences of surgery and the study
- Is scheduled to have bariatric surgery performed
- Has a negative pregnancy test
Who cannot join
- Repeat gastric bypass procedure
- Patients who are unable to hold their insulin coverage for 48 hours prior to research visits
- Patients taking TZDs
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University Brody School of Medicine
Greenville, North Carolina, 27834
About this study
Official title: Johnson and Johnson Ethicon Metabolomics of RYGB With Gastrostomy
This study is an investigation of the "metabolomics of RYGB with gastrostomy."
Read the detailed description
The rapid and durable remission of type II diabetes mellitis following the gastric bypass operation challenges the current concepts about the etiology of the disease. The surgery, which excludes food from the stomach, duodenum, and proximal jejunum, is quickly followed by a durable drop in glucose and insulin levels. As a result, 4 out of 5 diabetic, morbidly obese individuals who undergo the operation return to a long-term euglycemia with a prolongation of life and a reduction of health care costs.
The investigators at East Carolina University and those at Johnson and Johnson propose to further complete the profile of the upper gut by extending their observation to three additional human models. The investigators will study patients having the gastric band procedure, the gastric sleeve procedure, and those who have a gastric bypass but have a PEG tube inserted later.
- Conditions
- Type II Diabetes Mellitus, Obesity
- Being tested
- Gastric Band, Gastric Sleeve, Gastrostomy Tube
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric BandProcedure or surgery
Places a band over the upper portion of the stomach.
Gastric SleeveProcedure or surgery
Stapling stomach vertically to reduce size of stomach and removal of larger curve portion of the stomach
Gastrostomy TubeProcedure or surgery
Tube is inserted into the stomach that delivers nutrition directly into the stomach.
| Study group | Role | What they receive |
|---|---|---|
| Restricted food intake without rerouting food flow cohort | Obese non-diabetic patients and diabetic patients undergoing gastric band surgery will be studied before they have surgery, 1 week after the band is adjusted to restrict food intake and again after they have lost the weight equal to that which gastric bypass patients loose 3 months after surgery (to match data we already have in the current study). All patients will be studied with an intravenous glucose tolerance test to measure insulin sensitivity and IV glucose-induced insulin secretion and a meal challenge to measure the secretion of metabolites and peptides. Receives: Procedure: Gastric Band | |
| Response to meal when a portion of the stomach is excluded from food flow cohort | Obese-diabetic patient undergoing gastric sleeve surgery will be studied before they have surgery, 1 week after surgery and again 3-6 months after surgery (to match data we already have in the current study). The patient will be studied with an intravenous glucose tolerance test to measure insulin sensitivity and insulin secretion and a meal challenge to measure the secretion of metabolites and peptides. Receives: Procedure: Gastric Sleeve | |
| Response to meal when a portion of the GI tract is excluded from food flow cohort | In approximately 6 patients/year our surgeons have to insert a gastrostomy tube into the bypassed stomach of gastric bypass patients. This provides a unique opportunity to see the changes in metabolites and peptides in blood in response to a meal delivered to the bypassed stomach, duodenum and proximal jejunum. Since we can not anticipate which patients will require this procedure, we cannot do tests before surgery, but we will do four tests post-operatively: (1) an IV glucose tolerance test, (2) an oral meal challenge (with Hi-cal), and (3) a meal challenge (identical to that given orally/Hi-Cal) delivered through the gastrostomy tube.
Gastrostomy subjects will also have a 4) test, a 75 gram dextrose meal challenge. Receives: Procedure: Gastrostomy Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolics of RYGB with Gastrostomy - Insulin
The patient will be weighed after voiding. The weight will then be used to determine the amount of insulin to be administered during the minimal model. The following formulas will be used to calculate the insulin dosages:
REGULAR INSULIN: body mass (kg) X 0.025 U
Measured: 03/25/2009-10/12/2012
Metabolics of RYGB with Gastrostomy - Glucose
The patient will be weighed after voiding. The weight will then be used to determine the amount of glucose to be administered during the minimal model. The following formulas will be used to calculate the glucose dosages:
GLUCOSE: mls of 50% solution of glucose= body mass (kg) X 0.3g X 2
Measured: 03/25/2009-10/12/2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study start25 Mar 2009
- Primary completion12 Oct 2012
- Study completion12 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Walter Pories, MD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887302
- Sponsor's protocol ID
- J&J Ethicon
- Status last verified
- Oct 2023
- First submitted
- 22 Apr 2009
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Johnson and Johnson Ethicon Metabolomics of RYGB With Gastrostomy
- ClinicalTrials.gov ID
- NCT00887302
- Acronym / sponsor ID
- J&J Ethicon
- Conditions
- Type II Diabetes Mellitus, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 25 Mar 2009 (actual)
- Primary completion
- 12 Oct 2012 (actual)
- Study completion
- 12 Oct 2012 (actual)
- First posted
- 23 Apr 2009 (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.
This study is an investigation of the "metabolomics of RYGB with gastrostomy."
Detailed description
The rapid and durable remission of type II diabetes mellitis following the gastric bypass operation challenges the current concepts about the etiology of the disease. The surgery, which excludes food from the stomach, duodenum, and proximal jejunum, is quickly followed by a durable drop in glucose and insulin levels. As a result, 4 out of 5 diabetic, morbidly obese individuals who undergo the operation return to a long-term euglycemia with a prolongation of life and a reduction of health care costs.
The investigators at East Carolina University and those at Johnson and Johnson propose to further complete the profile of the upper gut by extending their observation to three additional human models. The investigators will study patients having the gastric band procedure, the gastric sleeve procedure, and those who have a gastric bypass but have a PEG tube inserted later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Restricted food intake without rerouting food flow cohort | – | Procedure: Gastric BandObese non-diabetic patients and diabetic patients undergoing gastric band surgery will be studied before they have surgery, 1 week after the band is adjusted to restrict food intake and again after they have lost the weight equal to that which gastric bypass patients loose 3 months after surgery (to match data we already have in the current study). All patients will be studied with an intravenous glucose tolerance test to measure insulin sensitivity and IV glucose-induced insulin secretion and a meal challenge to measure the secretion of metabolites and peptides. |
| Response to meal when a portion of the stomach is excluded from food flow cohort | – | Procedure: Gastric SleeveObese-diabetic patient undergoing gastric sleeve surgery will be studied before they have surgery, 1 week after surgery and again 3-6 months after surgery (to match data we already have in the current study). The patient will be studied with an intravenous glucose tolerance test to measure insulin sensitivity and insulin secretion and a meal challenge to measure the secretion of metabolites and peptides. |
| Response to meal when a portion of the GI tract is excluded from food flow cohort | – | Procedure: Gastrostomy TubeIn approximately 6 patients/year our surgeons have to insert a gastrostomy tube into the bypassed stomach of gastric bypass patients. This provides a unique opportunity to see the changes in metabolites and peptides in blood in response to a meal delivered to the bypassed stomach, duodenum and proximal jejunum. Since we can not anticipate which patients will require this procedure, we cannot do tests before surgery, but we will do four tests post-operatively: (1) an IV glucose tolerance test, (2) an oral meal challenge (with Hi-cal), and (3) a meal challenge (identical to that given orally/Hi-Cal) delivered through the gastrostomy tube. Gastrostomy subjects will also have a 4) test, a 75 gram dextrose meal challenge. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Obese caucasian females between the ages of 18-60 who have had bariatric surgery.
Key inclusion criteria (7 listed)
- Female
- 18-60 years of age
- BMI of 35-65
- Willing to comply with study requirements and long term follow-up
- Capable of understanding the requirements and consequences of surgery and the study
Key exclusion criteria (3 listed)
- Repeat gastric bypass procedure
- Patients who are unable to hold their insulin coverage for 48 hours prior to research visits
- Patients taking TZDs
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 |
|---|---|---|
| Gastric BandPlaces a band over the upper portion of the stomach. | Procedure or surgery | Restricted food intake without rerouting food flow cohort |
| Gastric SleeveStapling stomach vertically to reduce size of stomach and removal of larger curve portion of the stomach | Procedure or surgery | Response to meal when a portion of the stomach is excluded from food flow cohort |
| Gastrostomy TubeTube is inserted into the stomach that delivers nutrition directly into the stomach. | Procedure or surgery | Response to meal when a portion of the GI tract is excluded from food flow cohort |
Primary outcome
Metabolics of RYGB with Gastrostomy - Insulin
Time frame: 03/25/2009-10/12/2012
The patient will be weighed after voiding. The weight will then be used to determine the amount of insulin to be administered during the minimal model. The following formulas will be used to calculate the insulin dosages: REGULAR INSULIN: body mass (kg) X 0.025 U
Metabolics of RYGB with Gastrostomy - Glucose
Time frame: 03/25/2009-10/12/2012
The patient will be weighed after voiding. The weight will then be used to determine the amount of glucose to be administered during the minimal model. The following formulas will be used to calculate the glucose dosages: GLUCOSE: mls of 50% solution of glucose= body mass (kg) X 0.3g X 2
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 6 Oct 2023.
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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.
Walter Pories, MD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type II Diabetes Mellitus and Obesity, run by East Carolina 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 3 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 6 Oct 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.
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?
Metabolics of RYGB with Gastrostomy - Insulin (time frame: 03/25/2009-10/12/2012). The study lists 2 primary outcomes in all. 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 6 Oct 2023.