ObesityNCT03723486
Bariatric Surgery: Microbiome & Diabetes
An observational study of Obesity, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study is a prospective cohort study, following 80 morbidly obese patients undergoing bariatric surgery, specifically Roux-en-Y gastric bypass (RYGB). The investigators are measuring intestinal microbiota (IM) and oral microbiota (OM) at the beginning before any treatment, at the time of surgery, which is after a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to 30 Dec 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients undergoing RYGB surgery.
Who may be able to join
- Morbidly obese patients (BMI > 40 kg/m2 or BMI >35-40 kg/m2 with other severe weight loss responsive comorbidities, undergoing laparoscopic RYGB surgery).
Who cannot join
- regular intake of non-steroidal anti-inflammatory drugs; prebiotics, probiotics or antibiotics or any experimental drug in the 3 months prior to study entry; type 1 diabetes, chronic gastrointestinal diseases, previous gastrointestinal surgery modifying the anatomy, smoking; pregnancy or breastfeeding; patients not tolerating Optifast; bariatric surgery other than RYGB patients.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 1Z5
About this study
Official title: Changes in the Intestinal and Oral Microbiome of Morbidly Obese Patients Undergoing Gastric Bypass Surgery in Relation to Insulin Resistance and Metabolic Syndrome
This study is a prospective cohort study, following 80 morbidly obese patients undergoing bariatric surgery, specifically Roux-en-Y gastric bypass (RYGB). The investigators are measuring intestinal microbiota (IM) and oral microbiota (OM) at the beginning before any treatment, at the time of surgery, which is after a very low calorie standard diet, and 1 and 6 months after surgery. The investigators assess whether changes in IM are related to changes in insulin resistance (IR), other features of the metabolic syndrome (MetS) and OM.
Read the detailed description
Morbid obesity is associated with not only type 2 diabetes (T2D) of morbidly obese patients), but also cardiovascular complications, all of which remarkably improved and even resolved with bariatric surgery, of which the RYGB surgery has become the gold standard. Many studies have shown that within a few weeks post-RYGB there is dramatic improvement in IR and/or T2D independent of weight loss that ensues. These results led us to hypothesize that changes in intestinal microbiome (IM) composition and metagenome may be independently associated with improvement in metabolic parameters in humans undergoing RYGB.
Another aspect of RYGB that has not been studied is the potential changes in oral microbiome (OM) and salivary proteome (SP) and their relationship with weight loss and metabolic improvement. Understanding the OM and SP in morbidly obese patients before and after RYGB is important because shifts in the OM and SP may explain the susceptibility of these patients for oral infections like periodontal disease, which is more prevalent and severe in this population, particularly if T2D is present To our knowledge there are no longitudinal studies the relation between oral and intestinal microbiome before and after bariatric surgery. Furthermore, there are no studies looking at the effect of weight-reduction with the very low calorie diet (VLCD) Optifast regimen on IM, which the investigators plan to do. As IM may contribute to obesity and IR/T2D, the latter being the most dominant feature of the MetS. However, whether specific IM compositions are associated with improvement of obesity, IR/T2D and other features of the MetS is not clear; and the effects of RYGB on IM for treatment of these disorders in morbid obesity have not been well studied.
The investigators will conduct a prospective observational study of morbidly obese patients undergoing RYGB, in which the investigators will measure the intestinal microbiome before and after surgery along with insulin resistance and metabolic syndrome. Baseline measurements will be done before the pre-operative run-in with the very low calorie Optifast regimen (800 kcal/d) given before the laparoscopic RYGB (1 week/100 lbs body weight) to reduce the liver size for surgical access. Preoperatively, Optifast likely leads to changes in IM (never assessed) in addition to weight loss and improvement in MetS parameters. Aim: To track the changes in IM structure and function (metagenome) of morbidly obese patients undergoing laparoscopic RYGB through 3 stages - a) before vs. after pre-op Optifast weight reduction treatment 24; and post-op RYGB at b) 1 month; and at c) 6 months. The investigators will correlate the specific changes in IM through these stages, to improvement in IR and other features of the MetS. At the same time points the investigators will also measure the OM, salivary flow rate and SP, as well as oral inflammatory load.
- Conditions
- Obesity
- Keywords
- Morbidly obese, Insulin resistance, Metabolic syndrome, Intestinal microbiome, Gastric bypass, Oral microbiome
- Medical subject headings
- Obesity, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y gastric bypass surgery (RYGB) | Morbidly obese patients undergoing gastric bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HOMA-IR
HOMA-IR which represents insulin resistance and is calculated based on (glucose [mmol/L] x insulin [mU/L] / 22.5).
Measured: Change from Baseline HOMA-IR at 6 months post bariatric surgery
Secondary outcomes (23)
Stool Sample: 16S sequencing
Stool sample analysis
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Stool Sample: qPCR
Stool sample analysis
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Stool Sample: Short Chain fatty acid
Stool sample analysis
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Stool Sample: Metagenome.
Stool sample analysis
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Appetite assessment
Appetite questionnaire
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Anthropometry:Height
Anthropometric height
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Anthropometry: weight
Anthropometric weight
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Anthropometry: Waist circumference
Anthropometric measurements (measured in cm)
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Anthropometry: Hip-circumference
Anthropometric measurements (measured in cm)
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Questionnaires: Food record
General questionnaire
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Questionnaires: Activity Log
General questionnaire
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Questionnaires: Environmental questionnaire
General questionnaire
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Questionnaires: Dental questionnaire,
General questionnaire
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Oral microbiome: Saliva
Oral sample
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Oral microbiome: Mouth rinse
Oral sample
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Oral microbiome: Oral Plaque
Oral sample
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Oral microbiome: Tongue plaque
Oral sample
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
C peptide
Blood work measurements (measured in pmol/L)
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
HbA1c
Blood work measurements (measured in %)
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Glucose
Blood work measurement (measured mmol/L)
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Fasting Insulin
Blood work measurement (measured in pmol/L)
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Plasma endotoxin
Blood work measurement of lipopolysaccharide
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Gut Hormone
Blood work measurement
Measured: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study startNov 2015
- Primary completion30 Jun 2022
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Johane Allard, University Health Network, Toronto
- Investigators
- Johane P Allard, MD, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723486
- Sponsor's protocol ID
- 15-8784-AE
- Other IDs
- TB2-138775
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2017
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Lewis MC, Phillips ML, Slavotinek JP, Kow L, Thompson CH, Toouli J. Change in liver size and fat content after treatment with Optifast very low calorie diet. Obes Surg. 2006 Jun;16(6):697-701. doi: 10.1381/096089206777346682.
PubMed 16756727Chaffee BW, Weston SJ. Association between chronic periodontal disease and obesity: a systematic review and meta-analysis. J Periodontol. 2010 Dec;81(12):1708-24. doi: 10.1902/jop.2010.100321. Epub 2010 Aug 19.
PubMed 20722533Madsbad S, Dirksen C, Holst JJ. Mechanisms of changes in glucose metabolism and bodyweight after bariatric surgery. Lancet Diabetes Endocrinol. 2014 Feb;2(2):152-64. doi: 10.1016/S2213-8587(13)70218-3. Epub 2014 Feb 3.
PubMed 24622719Graessler J, Qin Y, Zhong H, Zhang J, Licinio J, Wong ML, Xu A, Chavakis T, Bornstein AB, Ehrhart-Bornstein M, Lamounier-Zepter V, Lohmann T, Wolf T, Bornstein SR. Metagenomic sequencing of the human gut microbiome before and after bariatric surgery in obese patients with type 2 diabetes: correlation with inflammatory and metabolic parameters. Pharmacogenomics J. 2013 Dec;13(6):514-22. doi: 10.1038/tpj.2012.43. Epub 2012 Oct 2.
PubMed 23032991Qin J, Li Y, Cai Z, Li S, Zhu J, Zhang F, Liang S, Zhang W, Guan Y, Shen D, Peng Y, Zhang D, Jie Z, Wu W, Qin Y, Xue W, Li J, Han L, Lu D, Wu P, Dai Y, Sun X, Li Z, Tang A, Zhong S, Li X, Chen W, Xu R, Wang M, Feng Q, Gong M, Yu J, Zhang Y, Zhang M, Hansen T, Sanchez G, Raes J, Falony G, Okuda S, Almeida M, LeChatelier E, Renault P, Pons N, Batto JM, Zhang Z, Chen H, Yang R, Zheng W, Li S, Yang H, Wang J, Ehrlich SD, Nielsen R, Pedersen O, Kristiansen K, Wang J. A metagenome-wide association study of gut microbiota in type 2 diabetes. Nature. 2012 Oct 4;490(7418):55-60. doi: 10.1038/nature11450. Epub 2012 Sep 26.
PubMed 23023125Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jorgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clement K, Dore J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium; Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.
PubMed 23985870Arimatsu K, Yamada H, Miyazawa H, Minagawa T, Nakajima M, Ryder MI, Gotoh K, Motooka D, Nakamura S, Iida T, Yamazaki K. Oral pathobiont induces systemic inflammation and metabolic changes associated with alteration of gut microbiota. Sci Rep. 2014 May 6;4:4828. doi: 10.1038/srep04828.
PubMed 24797416
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Intestinal and Oral Microbiome of Morbidly Obese Patients Undergoing Gastric Bypass Surgery in Relation to Insulin Resistance and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03723486
- Acronym / sponsor ID
- 15-8784-AE
- Conditions
- Obesity
- Keywords
- Morbidly obese, Insulin resistance, Metabolic syndrome, Intestinal microbiome, Gastric bypass, Oral microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2015 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 29 Oct 2018 (actual)
- 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 a prospective cohort study, following 80 morbidly obese patients undergoing bariatric surgery, specifically Roux-en-Y gastric bypass (RYGB). The investigators are measuring intestinal microbiota (IM) and oral microbiota (OM) at the beginning before any treatment, at the time of surgery, which is after a very low calorie standard diet, and 1 and 6 months after surgery. The investigators assess whether changes in IM are related to changes in insulin resistance (IR), other features of the metabolic syndrome (MetS) and OM.
Detailed description
Morbid obesity is associated with not only type 2 diabetes (T2D) of morbidly obese patients), but also cardiovascular complications, all of which remarkably improved and even resolved with bariatric surgery, of which the RYGB surgery has become the gold standard. Many studies have shown that within a few weeks post-RYGB there is dramatic improvement in IR and/or T2D independent of weight loss that ensues. These results led us to hypothesize that changes in intestinal microbiome (IM) composition and metagenome may be independently associated with improvement in metabolic parameters in humans undergoing RYGB.
Another aspect of RYGB that has not been studied is the potential changes in oral microbiome (OM) and salivary proteome (SP) and their relationship with weight loss and metabolic improvement. Understanding the OM and SP in morbidly obese patients before and after RYGB is important because shifts in the OM and SP may explain the susceptibility of these patients for oral infections like periodontal disease, which is more prevalent and severe in this population, particularly if T2D is present To our knowledge there are no longitudinal studies the relation between oral and intestinal microbiome before and after bariatric surgery. Furthermore, there are no studies looking at the effect of weight-reduction with the very low calorie diet (VLCD) Optifast regimen on IM, which the investigators plan to do. As IM may contribute to obesity and IR/T2D, the latter being the most dominant feature of the MetS. However, whether specific IM compositions are associated with improvement of obesity, IR/T2D and other features of the MetS is not clear; and the effects of RYGB on IM for treatment of these disorders in morbid obesity have not been well studied.
The investigators will conduct a prospective observational study of morbidly obese patients undergoing RYGB, in which the investigators will measure the intestinal microbiome before and after surgery along with insulin resistance and metabolic syndrome. Baseline measurements will be done before the pre-operative run-in with the very low calorie Optifast regimen (800 kcal/d) given before the laparoscopic RYGB (1 week/100 lbs body weight) to reduce the liver size for surgical access. Preoperatively, Optifast likely leads to changes in IM (never assessed) in addition to weight loss and improvement in MetS parameters. Aim: To track the changes in IM structure and function (metagenome) of morbidly obese patients undergoing laparoscopic RYGB through 3 stages - a) before vs. after pre-op Optifast weight reduction treatment 24; and post-op RYGB at b) 1 month; and at c) 6 months. The investigators will correlate the specific changes in IM through these stages, to improvement in IR and other features of the MetS. At the same time points the investigators will also measure the OM, salivary flow rate and SP, as well as oral inflammatory load.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y gastric bypass surgery (RYGB) | – | –Morbidly obese patients undergoing gastric bypass surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients undergoing RYGB surgery.
Key inclusion criteria (1 listed)
- Morbidly obese patients (BMI > 40 kg/m2 or BMI >35-40 kg/m2 with other severe weight loss responsive comorbidities, undergoing laparoscopic RYGB surgery).
Key exclusion criteria (1 listed)
- regular intake of non-steroidal anti-inflammatory drugs; prebiotics, probiotics or antibiotics or any experimental drug in the 3 months prior to study entry; type 1 diabetes, chronic gastrointestinal diseases, previous gastrointestinal surgery modifying the anatomy, smoking; pregnancy or breastfeeding; patients not tolerating Optifast; bariatric surgery other than RYGB patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in HOMA-IR
Time frame: Change from Baseline HOMA-IR at 6 months post bariatric surgery
HOMA-IR which represents insulin resistance and is calculated based on (glucose [mmol/L] x insulin [mU/L] / 22.5).
23 secondary outcomes
Stool Sample: 16S sequencing
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Stool Sample: qPCR
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Stool Sample: Short Chain fatty acid
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Stool Sample: Metagenome.
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Appetite assessment
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Anthropometry:Height
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Anthropometry: weight
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Anthropometry: Waist circumference
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Anthropometry: Hip-circumference
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Questionnaires: Food record
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Questionnaires: Activity Log
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Questionnaires: Environmental questionnaire
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Questionnaires: Dental questionnaire,
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Oral microbiome: Saliva
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Oral microbiome: Mouth rinse
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Oral microbiome: Oral Plaque
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Oral microbiome: Tongue plaque
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
C peptide
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
HbA1c
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Glucose
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Fasting Insulin
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Plasma endotoxin
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Gut Hormone
Time frame: 4 time points; pre-Optifast (baseline), post-Optifast (at the time of surgery), 1 and 6 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 16756727Lewis MC, Phillips ML, Slavotinek JP, Kow L, Thompson CH, Toouli J. Change in liver size and fat content after treatment with Optifast very low calorie diet. Obes Surg. 2006 Jun;16(6):697-701. doi: 10.1381/096089206777346682.
- Background: PubMed 20722533Chaffee BW, Weston SJ. Association between chronic periodontal disease and obesity: a systematic review and meta-analysis. J Periodontol. 2010 Dec;81(12):1708-24. doi: 10.1902/jop.2010.100321. Epub 2010 Aug 19.
- Background: PubMed 24622719Madsbad S, Dirksen C, Holst JJ. Mechanisms of changes in glucose metabolism and bodyweight after bariatric surgery. Lancet Diabetes Endocrinol. 2014 Feb;2(2):152-64. doi: 10.1016/S2213-8587(13)70218-3. Epub 2014 Feb 3.
- Background: PubMed 23032991Graessler J, Qin Y, Zhong H, Zhang J, Licinio J, Wong ML, Xu A, Chavakis T, Bornstein AB, Ehrhart-Bornstein M, Lamounier-Zepter V, Lohmann T, Wolf T, Bornstein SR. Metagenomic sequencing of the human gut microbiome before and after bariatric surgery in obese patients with type 2 diabetes: correlation with inflammatory and metabolic parameters. Pharmacogenomics J. 2013 Dec;13(6):514-22. doi: 10.1038/tpj.2012.43. Epub 2012 Oct 2.
- Background: PubMed 23023125Qin J, Li Y, Cai Z, Li S, Zhu J, Zhang F, Liang S, Zhang W, Guan Y, Shen D, Peng Y, Zhang D, Jie Z, Wu W, Qin Y, Xue W, Li J, Han L, Lu D, Wu P, Dai Y, Sun X, Li Z, Tang A, Zhong S, Li X, Chen W, Xu R, Wang M, Feng Q, Gong M, Yu J, Zhang Y, Zhang M, Hansen T, Sanchez G, Raes J, Falony G, Okuda S, Almeida M, LeChatelier E, Renault P, Pons N, Batto JM, Zhang Z, Chen H, Yang R, Zheng W, Li S, Yang H, Wang J, Ehrlich SD, Nielsen R, Pedersen O, Kristiansen K, Wang J. A metagenome-wide association study of gut microbiota in type 2 diabetes. Nature. 2012 Oct 4;490(7418):55-60. doi: 10.1038/nature11450. Epub 2012 Sep 26.
- Background: PubMed 23985870Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jorgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clement K, Dore J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium; Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.
- Background: PubMed 24797416Arimatsu K, Yamada H, Miyazawa H, Minagawa T, Nakajima M, Ryder MI, Gotoh K, Motooka D, Nakamura S, Iida T, Yamazaki K. Oral pathobiont induces systemic inflammation and metabolic changes associated with alteration of gut microbiota. Sci Rep. 2014 May 6;4:4828. doi: 10.1038/srep04828.
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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.
Johane P Allard, MD, FRCPC principal investigator
University Health Network, Toronto
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 University Health Network, Toronto at 1 site in Canada.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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 Canada. 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?
Results are not available in the source record.
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 HOMA-IR (time frame: Change from Baseline HOMA-IR at 6 months post bariatric surgery). 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 NCT03723486, which also lists 7 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 2 Nov 2022.