ObesityNCT04263376
Bariatric Surgery-Induced Shift in Gut Microbiome and NAFLD
An observational study of Obesity and Diabetes Mellitus, Type 2, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study is designed as a prospective pilot study for longitudinal assessment of fecal microbiome related to medical and surgical weight loss. The investigators follow the standard of care for perioperative and intraoperative management of study participants. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2, NAFLD
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 31 Jan 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who are in the evaluation process for Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) will be offered the opportunity to volunteer for this study.
Who may be able to join
- Be an eligible candidate for bariatric surgery based on standard criteria in place, have been enrolled in bariatric surgery program at Cleveland Clinic Main Campus, and have been cleared and approved for bariatric surgery by the BMI bariatric program and his/her health insurance
- Have a Body Mass Index (BMI) more than 35 kg/m2
- Have type 2 diabetes (T2D) (but not type 1 diabetes, see exclusion criteria) as defined by
- If untreated (as per ADA standards of care) FPG > or = 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h OR 2-h PG > or = 200 mg/dL (11.1 mmol/L) during OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water OR A1C > or = 6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay OR In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose > or = 200 mg/dL (11.1 mmol/L).
- the use of any antidiabetic drug or glucose lowering agent, including biguanides (metformin), thiazolidinediones, alpha-glucosidase inhibitors, sulfonylurea, meglitinides, DPP4-inhibitors, GLP1-agonists, SGLT2i, any type of insulin.
- Have the ability and willingness to participate in the study and agree to the study terms
- As a standard of care, have a negative urine pregnancy test prior to surgery for women of childbearing potential. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
Who cannot join
- Any contra-indication for bariatric surgery (standard of care)
- Lack of insurance coverage for bariatric surgery
- Diabetes mellitus other than T2D including Type 1 diabetes or Latent Autoimmune Diabetes of the Adult (LADA) as defined by personal history of diabetic ketoacidosis or by positive auto-antibodies to glutamic Acid Decarboxylase (GAD-65), Islet Cell Antibodies (ICA), Insulin Autoantibodies (IAA), or to protein tyrosine phosphatase (IA-2A) Monogenetic or neonatal diabetes
- Prior bariatric surgery of any kind.
- Known history of chronic liver disease except for NAFLD/NASH: hepatitis, positive serologic test result for hepatitis B surface antigen and/or hepatitis C antibody, alpha-1-antitrypsin deficiency.
- Known Gastrointestinal disorders including a known history of celiac disease and/or any other malabsorptive disorders or inflammatory bowel disease (Crohn's disease or ulcerative colitis).
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- Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 12 months.
- Smoking within the previous 3 months.
- Pregnancy.
- Malignancy within five years (except squamous cell and basal cell cancer of the skin). Subjects diagnosed with early / stage 1 cancer that have been successfully treated are eligible per Investigator discretion.
- Use of any medications (prescription or OTC), including herbal or other supplements for treatment of obesity, or liver conditions at the time of consent.
- Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study.
- Unable to understand the risks, realistic benefits and compliance requirements of each program.
- Use of investigational therapy or participation in any other clinical trial within 12 weeks prior to signing the ICF.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Bariatric Surgery-Induced Shift in Gut Microbiome Protect Against Non-Alcoholic Fatty Liver Disease? A Step Toward Replicating Metabolic Surgery Results Without Surgery
This study is designed as a prospective pilot study for longitudinal assessment of fecal microbiome related to medical and surgical weight loss. The investigators follow the standard of care for perioperative and intraoperative management of study participants. The only addition to the standard of care protocol will be collection of fecal samples at 3 time points. This will enable investigators to compare changes in and effects by microbiota after low-calorie diet versus after bariatric surgery .
- Conditions
- Obesity, Diabetes Mellitus, Type 2, NAFLD
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in human gut microbiota
Test for intrapersonal longitudinal changes in human gut microbiota in patients with obesity undergoing bariatric surgery at 3 time points: baseline (preoperative), after diet-induced non-surgical weight loss, and 3-months post-operative.
Metagenomic characterization of gut microbial communities will be longitudinally examined with human feces at 3 time points. Microbiota profiles will be assessed in fecal samples using V4 variable regions of the 16S rRNA gene by MiSeq 250-base paired-end multiplex sequencing. Moreover, total microbial cell counts in fecal samples will be determined using flow cytometry in order to have a quantitative microbiome profiling.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start24 Apr 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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 The Cleveland ClinicThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Aminian, The Cleveland Clinic
- Investigators
- Ali Aminian, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263376
- Sponsor's protocol ID
- CCF IRB 19-438
- Status last verified
- Jan 2023
- First submitted
- 27 Dec 2019
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Bariatric Surgery-Induced Shift in Gut Microbiome Protect Against Non-Alcoholic Fatty Liver Disease? A Step Toward Replicating Metabolic Surgery Results Without Surgery
- ClinicalTrials.gov ID
- NCT04263376
- Acronym / sponsor ID
- CCF IRB 19-438
- Conditions
- Obesity, Diabetes Mellitus, Type 2, NAFLD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 10 Feb 2020 (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 designed as a prospective pilot study for longitudinal assessment of fecal microbiome related to medical and surgical weight loss. The investigators follow the standard of care for perioperative and intraoperative management of study participants. The only addition to the standard of care protocol will be collection of fecal samples at 3 time points. This will enable investigators to compare changes in and effects by microbiota after low-calorie diet versus after bariatric surgery .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who are in the evaluation process for Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) will be offered the opportunity to volunteer for this study.
Key inclusion criteria (7 listed)
- Be an eligible candidate for bariatric surgery based on standard criteria in place, have been enrolled in bariatric surgery program at Cleveland Clinic Main Campus, and have been cleared and approved for bariatric surgery by the BMI bariatric program and his/her health insurance
- Have a Body Mass Index (BMI) more than 35 kg/m2
- Have type 2 diabetes (T2D) (but not type 1 diabetes, see exclusion criteria) as defined by
- Have the ability and willingness to participate in the study and agree to the study terms
- As a standard of care, have a negative urine pregnancy test prior to surgery for women of childbearing potential. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
Key exclusion criteria (14 listed)
- Any contra-indication for bariatric surgery (standard of care)
- Lack of insurance coverage for bariatric surgery
- Diabetes mellitus other than T2D including Type 1 diabetes or Latent Autoimmune Diabetes of the Adult (LADA) as defined by personal history of diabetic ketoacidosis or by positive auto-antibodies to glutamic Acid Decarboxylase (GAD-65), Islet Cell Antibodies (ICA), Insulin Autoantibodies (IAA), or to protein tyrosine phosphatase (IA-2A) Monogenetic or neonatal diabetes
- Prior bariatric surgery of any kind.
- Known history of chronic liver disease except for NAFLD/NASH: hepatitis, positive serologic test result for hepatitis B surface antigen and/or hepatitis C antibody, alpha-1-antitrypsin deficiency.
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
Changes in human gut microbiota
Time frame: 3 months after surgery
Test for intrapersonal longitudinal changes in human gut microbiota in patients with obesity undergoing bariatric surgery at 3 time points: baseline (preoperative), after diet-induced non-surgical weight loss, and 3-months post-operative. Metagenomic characterization of gut microbial communities will be longitudinally examined with human feces at 3 time points. Microbiota profiles will be assessed in fecal samples using V4 variable regions of the 16S rRNA gene by MiSeq 250-base paired-end multiplex sequencing. Moreover, total microbial cell counts in fecal samples will be determined using flow cytometry in order to have a quantitative microbiome profiling.
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 5 Jan 2023.
- 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.
Ali Aminian, MD principal investigator
The Cleveland Clinic
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 and Diabetes Mellitus, Type 2, run by The Cleveland Clinic 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 14 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 5 Jan 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?
Changes in human gut microbiota (time frame: 3 months 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 5 Jan 2023.