ObesityNCT02654496
Gut Microbiota Post Roux-en-Y Gastric Bypass Surgery
An observational study of Obesity, run by North Dakota State University at 1 site in United States.
Trial summary
The purpose of this study is to investigate mechanisms responsible for weight change in patients who have undergone weight loss surgery. Specifically, we will compare the gut microbiota, plasma bile acids, plasma gut peptides (GLP-1, GLP-2, and PYY), and plasma LPS in three groups of subjects: 3-5 years post gastric… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Meal challenge
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2017
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3-5 years post gastric bypass patients and control subjects
Who may be able to join
- Female
- Age 18-65
- 3-5 years post Roux-en-Y gastric bypass and experienced successful weight loss following surgery (up to n=10) or
- 3-5 years post Roux-en-Y gastric bypass and did not experience optimal weight loss following surgery (up to n=10) or
- Nonsurgical control participants who are approximately matched in sex, age, and BMI to the optimal weight loss group (up to n=10).
Who cannot join
- Tobacco use in past three months.
- Taking a medication which is known to significantly influence gastrointestinal transit time or affect the microbiome or other variables significantly (as determined by study pharmacist/MD).
- History of diabetes mellitus.
- Has taken an oral or IV/IM antibiotic in the past 3 months.
- Has taken probiotic and/or prebiotic agent in the past 3 months
- History of significant intestinal disease or disorder (e.g., Crohn's disease, ulcerative colitis, irritable bowel syndrome)
Show all 12Show fewer
- History of gastrointestinal surgery that may impact measures of biological variables, as determined by the investigator.
- Medical condition expected to impact the biological variables of interest or interfere with providing a sample, as determined by the investigator.
- Unable to speak/read English.
- Breastfeeding, pregnant, or planning to become pregnant within the duration of the study.
- Unwilling to use a medically acceptable form of contraception.
- History of bipolar or psychotic spectrum disorder or alcohol or substance treatment in the past year
Trial locations and contacts
1 site in 1 country.
United States1 site
North Dakota State University/Sanford Health
Fargo, North Dakota, 58103
About this study
Official title: The Gut Microbiota in Patients Post Roux-en-Y Gastric Bypass Surgery
The purpose of this study is to investigate mechanisms responsible for weight change in patients who have undergone weight loss surgery. Specifically, we will compare the gut microbiota, plasma bile acids, plasma gut peptides (GLP-1, GLP-2, and PYY), and plasma LPS in three groups of subjects: 3-5 years post gastric bypass patients who experienced sub-optimal weight loss, 3-5 years post gastric bypass patients who had successful weight loss, and a control group who has not had a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass groups.
- Conditions
- Obesity
- Being tested
- Meal challenge
- Keywords
- Gut Microbiota, Weight Regain, Gastric Bypass
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal challengeOther
Participants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Successful weight loss) | 3-5 years post Roux-en-Y gastric bypass patients who had successful weight loss Receives: Other: Meal challenge | |
| Group 2 (Suboptimal weight loss) | 3-5 years post Roux-en-Y gastric bypass patients who had suboptimal weight loss Receives: Other: Meal challenge | |
| Group 3 (Control group) | A control group who has not had Roux-en-Y gastric bypass surgery and are of similar age, gender, body mass index as the gastric bypass groups. Receives: Other: Meal challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal Microbiome Composition. The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.
Measured: 3-5 years post RYGB
Secondary outcomes (3)
Plasma levels of cholic acid, chenodeoxy cholic acids, deoxycholic acid, and lithocholic acid will be measured by LCMS and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.
Measured: 3-5 years post RYGB
Plasma levels of GLP-1, GLP-2, and PYY will be measured by ELISA and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.
Measured: 3-5 years post RYGB
Plasma levels of Lipopolysaccharide (LPS) will be measured by the Limulus Amebocyte Lysate (LAL) assay and will be compared between successful weight loss and poor weigh loss post-RYGB and control groups.
Measured: 3-5 years post RYGB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristine Steffen, North Dakota State University
- Investigators
- Kristine Steffen, PharmD.,Ph.D, Principal investigator, North Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654496
- Sponsor's protocol ID
- IRB-201509-061
- Status last verified
- Aug 2018
- First submitted
- 17 Dec 2015
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PubMed 24570244Fouladi F, Brooks AE, Fodor AA, Carroll IM, Bulik-Sullivan EC, Tsilimigras MCB, Sioda M, Steffen KJ. The Role of the Gut Microbiota in Sustained Weight Loss Following Roux-en-Y Gastric Bypass Surgery. Obes Surg. 2019 Apr;29(4):1259-1267. doi: 10.1007/s11695-018-03653-y.
PubMed 30604078
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut Microbiota in Patients Post Roux-en-Y Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT02654496
- Acronym / sponsor ID
- IRB-201509-061
- Conditions
- Obesity
- Keywords
- Gut Microbiota, Weight Regain, Gastric Bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Jan 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 investigate mechanisms responsible for weight change in patients who have undergone weight loss surgery. Specifically, we will compare the gut microbiota, plasma bile acids, plasma gut peptides (GLP-1, GLP-2, and PYY), and plasma LPS in three groups of subjects: 3-5 years post gastric bypass patients who experienced sub-optimal weight loss, 3-5 years post gastric bypass patients who had successful weight loss, and a control group who has not had a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass groups.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Successful weight loss) | – | Other: Meal challenge3-5 years post Roux-en-Y gastric bypass patients who had successful weight loss |
| Group 2 (Suboptimal weight loss) | – | Other: Meal challenge3-5 years post Roux-en-Y gastric bypass patients who had suboptimal weight loss |
| Group 3 (Control group) | – | Other: Meal challengeA control group who has not had Roux-en-Y gastric bypass surgery and are of similar age, gender, body mass index as the gastric bypass groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3-5 years post gastric bypass patients and control subjects
Key inclusion criteria (5 listed)
- Female
- Age 18-65
- 3-5 years post Roux-en-Y gastric bypass and experienced successful weight loss following surgery (up to n=10) or
- 3-5 years post Roux-en-Y gastric bypass and did not experience optimal weight loss following surgery (up to n=10) or
- Nonsurgical control participants who are approximately matched in sex, age, and BMI to the optimal weight loss group (up to n=10).
Key exclusion criteria (12 listed)
- Tobacco use in past three months.
- Taking a medication which is known to significantly influence gastrointestinal transit time or affect the microbiome or other variables significantly (as determined by study pharmacist/MD).
- History of diabetes mellitus.
- Has taken an oral or IV/IM antibiotic in the past 3 months.
- Has taken probiotic and/or prebiotic agent in the past 3 months
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 |
|---|---|---|
| Meal challengeParticipants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected. | Other | Group 1 (Successful weight loss), Group 2 (Suboptimal weight loss), Group 3 (Control group) |
Primary outcome
Intestinal Microbiome Composition. The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.
Time frame: 3-5 years post RYGB
3 secondary outcomes
Plasma levels of cholic acid, chenodeoxy cholic acids, deoxycholic acid, and lithocholic acid will be measured by LCMS and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.
Time frame: 3-5 years post RYGB
Plasma levels of GLP-1, GLP-2, and PYY will be measured by ELISA and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.
Time frame: 3-5 years post RYGB
Plasma levels of Lipopolysaccharide (LPS) will be measured by the Limulus Amebocyte Lysate (LAL) assay and will be compared between successful weight loss and poor weigh loss post-RYGB and control groups.
Time frame: 3-5 years post RYGB
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 23 Aug 2018.
- Background: PubMed 24570244Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
- Derived from this study: PubMed 30604078Fouladi F, Brooks AE, Fodor AA, Carroll IM, Bulik-Sullivan EC, Tsilimigras MCB, Sioda M, Steffen KJ. The Role of the Gut Microbiota in Sustained Weight Loss Following Roux-en-Y Gastric Bypass Surgery. Obes Surg. 2019 Apr;29(4):1259-1267. doi: 10.1007/s11695-018-03653-y.
- Individual participant dataSharing planned: No
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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.
Kristine Steffen, PharmD.,Ph.D principal investigator
North Dakota State 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 Obesity, run by North Dakota State 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 5 inclusion and 12 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 23 Aug 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.
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?
Intestinal Microbiome Composition. The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation. (time frame: 3-5 years post RYGB). 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 NCT02654496, which also lists 2 linked publications.
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 23 Aug 2018.