Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
What are the benefits of undergoing Roux-en-Y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose | Blood sample taken after an overnight fast. | At baseline and 12 weeks post intervention |
| Fasting Glucose | Blood sample taken after an overnight fast. | 4 weeks post intervention |
| Peak Glucose | Blood sample taken after a meal. | baseline and 12 weeks post intervention |
| Peak Glucose | Blood sample taken after a meal. | 4 weeks post intervention |
| Glucose AUC | Area under the curve calculated from Oral Glucose Tolerance Test | 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 | baseline and 12 weeks post intervention |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Meera Shah, MBChB | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects that have undergone Roux-en-Y Gastric Bypass (RYGB) and were enrolled in the RYGB arm of trial period 'Study 1-RYGB vs Caloric Restriction', will be enrolled in the second trial period 'Study 2-Exendin (9,39) Amide study' 4 weeks postoperatively.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Roux-en-Y Gastric Bypass (RYGB): 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. |
| FG001 | Caloric Restriction | 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. Caloric Restriction: 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. |
| FG002 | Exendin-9,39 | 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. Exendin-9,39: 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. |
| FG003 | Normal Saline | 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. Normal Saline: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study 1 - RYGB vs Caloric Restriction |
|
| ||||||||||||||||||
| Study 2 - Exendin (9,39) Amide Study |
|
A total of 12 participants were enrolled in the overall study, which was comprised of two separate studies. One participant completed and was analyzed for both studies, resulting in a total of 13 participants analyzed for the Baseline Measures overall.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Roux-en-Y Gastric Bypass (RYGB): 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data collected from each study are being reported separately to avoid multi-counted participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fasting Glucose | Blood sample taken after an overnight fast. | Posted | Mean | Standard Deviation | mmol/l | At baseline and 12 weeks post intervention |
|
Adverse events were collected from baseline to end of study participation for a total of approximately 12 weeks on all participants.
Number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero for the saline arm because no participants were enrolled in the saline arm of study 2- Exendin (9,39) Amide study period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Roux-en-Y Gastric Bypass (RYGB): 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meera Shah, MB, ChB | Mayo Clinic | 507-284-0106 | Shah.Meera@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2017 | Feb 4, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| D050110 | Bariatric Surgery |
| D031204 | Caloric Restriction |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D005763 | Gastroenterostomy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Caloric Restriction | Behavioral | 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-9,39 | Drug | 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 Saline | Drug | 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. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Caloric Restriction | 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. Caloric Restriction: 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. |
| BG002 | Exendin-9,39 | 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. Exendin-9,39: 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. |
| BG003 | Normal Saline | 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. Normal Saline: 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. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Data collected from each study are being reported separately to avoid multi-counted participants. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Data collected from each study are being reported separately to avoid multi-counted participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data collected from each study are being reported separately to avoid multi-counted participants. | Count of Participants | Participants |
|
| Region of Enrollment | Study 1-RYGB vs Caloric Restriction. | Data collected from each study are being reported separately to avoid multi-counted participants. | Number | participants |
|
| Region of Enrollment | Study 2-Exendin (9,39) Amide Study | Data collected from each study are being reported separately to avoid multi-counted participants. | Number | participants |
|
|
|
| Primary | Fasting Glucose | Blood sample taken after an overnight fast. | 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. | Posted | Number | mmol/l | 4 weeks post intervention |
|
|
|
| Primary | Peak Glucose | Blood sample taken after a meal. | Posted | Mean | Standard Deviation | mmol/l | baseline and 12 weeks post intervention |
|
|
|
| Primary | Peak Glucose | Blood sample taken after a meal. | 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. | Posted | Number | mmol/l | 4 weeks post intervention |
|
|
|
| Primary | Glucose AUC | Area under the curve calculated from Oral Glucose Tolerance Test | Posted | Mean | Standard Deviation | mmol/l.min | 0 to 360 minutes post-meal at Baseline and 12 weeks post-intervention |
|
|
|
| Primary | Changes in the Gut Microbiome Following RYGB or Caloric Restriction | Stool sample collection for gut microbiome analysis | No participants samples were analyzed due to inability to obtain funding to proceed with gut microbiome analysis. | Posted | baseline and 12 weeks post intervention |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Caloric Restriction | 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. Caloric Restriction: 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Exendin-9,39 | 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. Exendin-9,39: 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | Normal Saline | 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. Normal Saline: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D000714 |
| Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D002149 | Energy Intake |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| >=65 years |
|
|
| Male |
|
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|