Type 2 Diabetes MellitusPhase 2MicrobiomeNCT02762708

The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes

A Phase 2 study testing Roux-en-Y Gastric Bypass (RYGB), Caloric Restriction and Exendin-9,39 in people with Type 2 Diabetes Mellitus and Obesity, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone? Read more about this study

Who is it for?: Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus, Obesity
What is being tested?: Roux-en-Y Gastric Bypass (RYGB), Caloric Restriction and Exendin-9,39
Type of treatment: Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Mar 2016to 6 Jan 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 20-65 years of age.
Seen at Mayo Clinic Nutrition Clinic and have received authorization for RYGB surgery.
Type 2 Diabetes Mellitus or impaired fasting glucose with BMI >35 AND not interested in surgery but are interested in supervised caloric restriction.

Who cannot join

Previous treatment with thiazolidinediones.
Chronic antibiotic therapy.
Active microvascular or macrovascular complications of diabetes.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: The Effect of Bariatric Surgery on Metabolism, the Metabolome and the Microbiome in Patients With Type 2 Diabetes

What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?

Read the detailed description

Roux-en-y gastric bypass (RYGB) surgery leads to improvements in diabetes that occurs even before any significant weight loss is seen. What are the reasons for this? There is evidence in animals that changes in the composition of gut bacteria after RYGB may be responsible for improvements in how glucose is metabolized in the body. The study aims to correlate changes in the bacterial composition of the gut that occurs after surgery with improvements in glucose metabolism in people with type 2 diabetes. The investigators will do this by using validated methods to measure glucose metabolism and cutting edge technology to analyze the gut microbiome. A parallel group of patients with similar weight, height and age will undergo caloric restriction alone to mimic weight loss seen after RYGB. Participants will also undergo similar glucose metabolism studies and analysis of their gut bacterial composition. Thus, any difference seen between groups can be attributed to the surgery itself and may lead to identification of novel therapeutic options for diabetes.

Conditions: Type 2 Diabetes Mellitus, Obesity
Being tested: Roux-en-Y Gastric Bypass (RYGB), Caloric Restriction, Exendin-9,39, Normal Saline
Keywords: Bariatric Surgery, Weight loss
Medical subject headings: Diabetes Mellitus, Type 2, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Roux-en-Y Gastric Bypass (RYGB)Procedure or surgery
Also called Bariatric Surgery
Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery.
Caloric RestrictionBehavioural
Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.
Exendin-9,39Drug
A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.
Normal SalineDrug
subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.

Study groups in NCT02762708
Study group	Role	What they receive
Roux-en-Y Gastric Bypass (RYGB)	Active comparator	Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB. Receives: Procedure: Roux-en-Y Gastric Bypass (RYGB)
Caloric restriction	Sham comparator	Subjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery. Receives: Behavioral: Caloric Restriction
Exendin-9,39	Active comparator	Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Receives: Drug: Exendin-9,39
Normal Saline	Placebo comparator	Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline. Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Fasting Glucose
Blood sample taken after an overnight fast.
Measured: At baseline and 12 weeks post intervention
Fasting Glucose
Blood sample taken after an overnight fast.
Measured: 4 weeks post intervention
Peak Glucose
Blood sample taken after a meal.
Measured: baseline and 12 weeks post intervention
Peak Glucose
Blood sample taken after a meal.
Measured: 4 weeks post intervention
Glucose AUC
Area under the curve calculated from Oral Glucose Tolerance Test
Measured: 0 to 360 minutes post-meal at Baseline and 12 weeks post-intervention
Changes in the Gut Microbiome Following RYGB or Caloric Restriction
Stool sample collection for gut microbiome analysis
Measured: baseline and 12 weeks post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 20166 Jan 2018

First posted5 May 2016 (estimated)
Study startMar 2016
Primary completion6 Jan 2018
Study completion6 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Mayo 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: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02762708
Sponsor's protocol ID: 15-000179
Acronym: Microbiome
Status last verified: Apr 2022
First submitted: 3 May 2016
Last updated: 3 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Bariatric Surgery on Metabolism, the Metabolome and the Microbiome in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT02762708
Acronym / sponsor ID: Microbiome / 15-000179
Conditions: Type 2 Diabetes Mellitus, Obesity
Keywords: Bariatric Surgery, Weight loss
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: Mar 2016
Primary completion: 6 Jan 2018 (actual)
Study completion: 6 Jan 2018 (actual)
First posted: 5 May 2016 (estimated)
Results: Posted 3 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Roux-en-Y Gastric Bypass (RYGB)	Active comparator	Procedure: Roux-en-Y Gastric Bypass (RYGB)Subjects between the ages of 20-65 years of age seen for weight management in the Nutrition Clinic at Mayo Clinic, who have been approved for RYGB.
Caloric restriction	Sham comparator	Behavioral: Caloric RestrictionSubjects between the ages of 20-65 years of age, with diagnosis of Type 2 diabetes mellitus or impaired fasting glucose. Subjects will undergo caloric restriction alone to mimic weight loss seen after gastric bypass surgery.
Exendin-9,39	Active comparator	Drug: Exendin-9,39Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.
Normal Saline	Placebo comparator	Drug: Normal SalineFour subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 20-65 years of age.
Seen at Mayo Clinic Nutrition Clinic and have received authorization for RYGB surgery.
Type 2 Diabetes Mellitus or impaired fasting glucose with BMI >35 AND not interested in surgery but are interested in supervised caloric restriction.

Key exclusion criteria (3 listed)

Previous treatment with thiazolidinediones.
Chronic antibiotic therapy.
Active microvascular or macrovascular complications of diabetes.

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
Roux-en-Y Gastric Bypass (RYGB)Also: Bariatric SurgerySubjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery.	Procedure or surgery	Roux-en-Y Gastric Bypass (RYGB)
Caloric RestrictionSubjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.	Behavioural	Caloric restriction
Exendin-9,39A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.	Drug	Exendin-9,39
Normal Salinesubset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.	Drug	Normal Saline

Primary outcome

Fasting Glucose
Time frame: At baseline and 12 weeks post intervention
Blood sample taken after an overnight fast.
Fasting Glucose
Time frame: 4 weeks post intervention
Blood sample taken after an overnight fast.
Peak Glucose
Time frame: baseline and 12 weeks post intervention
Blood sample taken after a meal.
Peak Glucose
Time frame: 4 weeks post intervention
Blood sample taken after a meal.
Glucose AUC
Time frame: 0 to 360 minutes post-meal at Baseline and 12 weeks post-intervention
Area under the curve calculated from Oral Glucose Tolerance Test
Changes in the Gut Microbiome Following RYGB or Caloric Restriction
Time frame: baseline and 12 weeks post intervention
Stool sample collection for gut microbiome analysis

Results and safety

Results posted to the registry on 3 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Roux-en-Y Gastric Bypass (RYGB)	3	3
Caloric Restriction	9	7
Exendin-9,39	0	0
Normal Saline	0	0

Primary outcome: Fasting Glucose

Time frame: At baseline and 12 weeks post intervention. Mean (Standard Deviation). Unit: mmol/l

Measure	Roux-en-Y Gastric Bypass (RYGB) n = 3	Caloric Restriction n = 7
Baseline	6.1 (0.88)	7.23 (0.98)
12 weeks post intervention	6.48 (1.7)	5.89 (0.4)

Primary outcome: Fasting Glucose

Time frame: 4 weeks post intervention. Number. Unit: mmol/l

Measure	Exendin-9,39 n = 1	Normal Saline n = 0
Value	4.75	–

Population analysed: The number of participants analyzed for the Normal Saline group at 4 weeks post intervention is zero because no subjects were enrolled in this arm.

Primary outcome: Peak Glucose

Time frame: baseline and 12 weeks post intervention. Mean (Standard Deviation). Unit: mmol/l

Measure	Roux-en-Y Gastric Bypass (RYGB) n = 3	Caloric Restriction n = 7
Baseline	11.35 (1.5)	10.84 (1.39)
12 weeks post intervention	11.8 (3.25)	10.04 (0.54)

Primary outcome: Peak Glucose

Time frame: 4 weeks post intervention. Number. Unit: mmol/l

Measure	Exendin-9,39 n = 1	Normal Saline n = 0
Value	8.15	–

Population analysed: The number of participants analyzed for the Normal Saline group at 4 weeks post intervention is zero because no subjects were enrolled in this arm.

Adverse events

Time frame: Adverse events were collected from baseline to end of study participation for a total of approximately 12 weeks on all participants.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Roux-en-Y Gastric Bypass (RYGB)	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Caloric Restriction	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Exendin-9,39	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Normal Saline	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Only one patient was enrolled in the trial period 'Study 2-Exendin (9,39) Amide study' 4 weeks post operatively. There were logistical challenges to recruiting patients 4 weeks post operatively as operation dates were not always known to the study team in time and patients did not feel well enough to come in for a study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
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.

Meera Shah, MBChB principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Roux-en-Y Gastric Bypass (RYGB), Caloric Restriction and Exendin-9,39 in people with Type 2 Diabetes Mellitus and Obesity, run by Mayo 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 3 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 3 May 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 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Fasting Glucose (time frame: At baseline and 12 weeks post intervention). The study lists 6 primary outcomes in all. 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 NCT02762708.

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 3 May 2022.