Trial Outcomes & Findings for The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes (NCT NCT02762708)
NCT ID: NCT02762708
Last Updated: 2022-05-03
Results Overview
Blood sample taken after an overnight fast.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
At baseline and 12 weeks post intervention
Results posted on
2022-05-03
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Study 1 - RYGB vs Caloric Restriction
STARTED
|
3
|
9
|
0
|
0
|
|
Study 1 - RYGB vs Caloric Restriction
COMPLETED
|
3
|
7
|
0
|
0
|
|
Study 1 - RYGB vs Caloric Restriction
NOT COMPLETED
|
0
|
2
|
0
|
0
|
|
Study 2 - Exendin (9,39) Amide Study
STARTED
|
0
|
0
|
1
|
0
|
|
Study 2 - Exendin (9,39) Amide Study
COMPLETED
|
0
|
0
|
1
|
0
|
|
Study 2 - Exendin (9,39) Amide Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Study 1 - RYGB vs Caloric Restriction
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
Baseline Characteristics
Data collected from each study are being reported separately to avoid multi-counted participants.
Baseline characteristics by cohort
| Measure |
Roux-en-Y Gastric Bypass (RYGB)
n=3 Participants
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.
|
Caloric Restriction
n=9 Participants
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.
|
Exendin-9,39
n=1 Participants
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.
|
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.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Study 1-RYGB vs Caloric Restriction · <=18 years
|
0 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
0 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
—
|
0 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Age, Categorical
Study 1-RYGB vs Caloric Restriction · Between 18 and 65 years
|
3 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
9 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
—
|
12 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Age, Categorical
Study 1-RYGB vs Caloric Restriction · >=65 years
|
0 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
0 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
—
|
0 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Age, Categorical
Study 2-Exendin (9,39) Amide Study · <=18 years
|
—
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Age, Categorical
Study 2-Exendin (9,39) Amide Study · Between 18 and 65 years
|
—
|
—
|
1 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
1 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Age, Categorical
Study 2-Exendin (9,39) Amide Study · >=65 years
|
—
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Sex: Female, Male
Study 1-RYGB vs Caloric Restriction · Female
|
2 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
6 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
Data collected from each study are being reported separately to avoid multi-counted participants.
|
8 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Sex: Female, Male
Study 1-RYGB vs Caloric Restriction · Male
|
1 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
3 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
Data collected from each study are being reported separately to avoid multi-counted participants.
|
4 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Sex: Female, Male
Study 2-Exendin (9,39) Amide Study · Female
|
—
|
—
|
1 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
1 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Sex: Female, Male
Study 2-Exendin (9,39) Amide Study · Male
|
—
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Ethnicity (NIH/OMB)
Study 1-RYGB vs Caloric Restriction · Hispanic or Latino
|
0 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
0 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
Data collected from each study are being reported separately to avoid multi-counted participants.
|
0 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Ethnicity (NIH/OMB)
Study 1-RYGB vs Caloric Restriction · Not Hispanic or Latino
|
1 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
0 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
Data collected from each study are being reported separately to avoid multi-counted participants.
|
1 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Ethnicity (NIH/OMB)
Study 1-RYGB vs Caloric Restriction · Unknown or Not Reported
|
2 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
9 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
Data collected from each study are being reported separately to avoid multi-counted participants.
|
11 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Ethnicity (NIH/OMB)
Study 2-Exendin (9,39) Amide Study · Hispanic or Latino
|
—
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Ethnicity (NIH/OMB)
Study 2-Exendin (9,39) Amide Study · Not Hispanic or Latino
|
—
|
—
|
1 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
1 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Ethnicity (NIH/OMB)
Study 2-Exendin (9,39) Amide Study · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 1-RYGB vs Caloric Restriction · American Indian or Alaska Native
|
0 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
0 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
—
|
0 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 1-RYGB vs Caloric Restriction · Asian
|
0 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
0 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
—
|
0 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 1-RYGB vs Caloric Restriction · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
0 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
—
|
0 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 1-RYGB vs Caloric Restriction · Black or African American
|
0 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
0 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
—
|
0 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 1-RYGB vs Caloric Restriction · White
|
3 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
9 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
—
|
12 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 1-RYGB vs Caloric Restriction · More than one race
|
0 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
0 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
—
|
0 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 1-RYGB vs Caloric Restriction · Unknown or Not Reported
|
0 Participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
0 Participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
—
|
0 Participants
n=12 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 2-Exendin (9,39) Amide Study · American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 2-Exendin (9,39) Amide Study · Asian
|
—
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 2-Exendin (9,39) Amide Study · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 2-Exendin (9,39) Amide Study · Black or African American
|
—
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 2-Exendin (9,39) Amide Study · White
|
—
|
—
|
1 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
1 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 2-Exendin (9,39) Amide Study · More than one race
|
—
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Race (NIH/OMB)
Study 2-Exendin (9,39) Amide Study · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
0 Participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
9 participants
n=9 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
1 participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
—
|
1 participants
n=1 Participants • Data collected from each study are being reported separately to avoid multi-counted participants.
|
PRIMARY outcome
Timeframe: At baseline and 12 weeks post interventionBlood sample taken after an overnight fast.
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass (RYGB)
n=3 Participants
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.
|
Caloric Restriction
n=7 Participants
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.
|
|---|---|---|
|
Fasting Glucose
Baseline
|
6.1 mmol/l
Standard Deviation 0.88
|
7.23 mmol/l
Standard Deviation 0.98
|
|
Fasting Glucose
12 weeks post intervention
|
6.48 mmol/l
Standard Deviation 1.7
|
5.89 mmol/l
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: 4 weeks post interventionPopulation: 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.
Blood sample taken after an overnight fast.
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass (RYGB)
n=1 Participants
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.
|
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.
|
|---|---|---|
|
Fasting Glucose
|
4.75 mmol/l
|
—
|
PRIMARY outcome
Timeframe: baseline and 12 weeks post interventionBlood sample taken after a meal.
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass (RYGB)
n=3 Participants
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.
|
Caloric Restriction
n=7 Participants
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.
|
|---|---|---|
|
Peak Glucose
Baseline
|
11.35 mmol/l
Standard Deviation 1.5
|
10.84 mmol/l
Standard Deviation 1.39
|
|
Peak Glucose
12 weeks post intervention
|
11.8 mmol/l
Standard Deviation 3.25
|
10.04 mmol/l
Standard Deviation 0.54
|
PRIMARY outcome
Timeframe: 4 weeks post interventionPopulation: 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.
Blood sample taken after a meal.
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass (RYGB)
n=1 Participants
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.
|
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.
|
|---|---|---|
|
Peak Glucose
|
8.15 mmol/l
|
—
|
PRIMARY outcome
Timeframe: 0 to 360 minutes post-meal at Baseline and 12 weeks post-interventionArea under the curve calculated from Oral Glucose Tolerance Test
Outcome measures
| Measure |
Roux-en-Y Gastric Bypass (RYGB)
n=3 Participants
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.
|
Caloric Restriction
n=7 Participants
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.
|
|---|---|---|
|
Glucose AUC
Baseline
|
2815 mmol/l.min
Standard Deviation 223
|
2715 mmol/l.min
Standard Deviation 375
|
|
Glucose AUC
12 weeks post intervention
|
3146 mmol/l.min
Standard Deviation 1186
|
2380 mmol/l.min
Standard Deviation 139
|
PRIMARY outcome
Timeframe: baseline and 12 weeks post interventionPopulation: No participants samples were analyzed due to inability to obtain funding to proceed with gut microbiome analysis.
Stool sample collection for gut microbiome analysis
Outcome measures
Outcome data not reported
Adverse Events
Roux-en-Y Gastric Bypass (RYGB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caloric Restriction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exendin-9,39
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place