Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Bariatric surgery, Obesity, Weight loss
Brief summary
The purpose of this study is to evaluate the mechanisms leading to rapid postoperative improvement in diabetes following Gastric By-Pass surgery for obesity.We will evaluate and compare the changes in glucose level, beta-cell function, and insulin resistance induced by a week of very low calorie liquid diet and those induced by a week of matched very -low calorie liquid diet occuring in the context of routine postoperative care following RYGB.
Detailed description
Volunteers planned to undergo RYGB will be studied during two-9 days periods of identical and controlled diet and activity, separated by a 4-10-week washout period. Study Period #1: This first study period is 9 days/nights long and requires you to be closely supervised at our Clinical and Translational Research Center (CTRC). During this time you will receive the same diet and are expected to have the same activity level you will be prescribed in the immediate post-operative period. Wash-out period: During this study period you are expected to return to your usual diet and exercise level. Study Period #2: This last study period is also 9 days/nights long, includes the EXACT same diet you have received during the first study period, and in addition you will undergo the planned gastric by-pass surgery. Procedures during the research: Mixed Meal Challenge test will be done four times during the entire study: days 1 and 9 for each study period. This test allows the investigators to evaluate how much insulin your body is producing and how well this insulin is processed. Measurement of resting energy expenditure will be done four times during the entire study. This test tell us how much energy your body is burning up in a resting state.
Interventions
None listed
Sponsors
University of Texas Southwestern Medical Center
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* volunteers that are planned to undergo RYGB(Roux-en-Y By pass) and have type 2 diabetes diagnosed within the prior 10 years.
Exclusion criteria
* abnormal renal function * significant anemia * difficult venous access * treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months * recent change in use of any pharmacologic agent with potential effect on either beta-cell function or insulin resistance. * pregnancy * non -English speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery | 4-12 weeks | Changes in the glucose Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucose AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule. |
| Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery | 4-12 weeks | Changes in the Insulin Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the insulin AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule. |
| Response in Glucagon AUC at Baseline vs. Following Gastric Bypass | 4-12 weeks | Changes in the glucagon Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucagon AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diet Only Group Patients on diet and activity protocol typical for patients after bariatric surgery | 12 |
| Surgery and Diet Group Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery. | 10 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Both subjects refused surgery | 2 | 0 |
Baseline characteristics
| Characteristic | Surgery and Diet Group | Diet Only Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 10 Participants | 18 Participants |
| Age, Continuous | 53.2 years STANDARD_DEVIATION 8.4 | 53.7 years STANDARD_DEVIATION 8.1 | 53.7 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
Primary
Response in Glucagon AUC at Baseline vs. Following Gastric Bypass
Changes in the glucagon Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucagon AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule.
Time frame: 4-12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet Only Group | Response in Glucagon AUC at Baseline vs. Following Gastric Bypass | 24332.8 pg/mL*min |
| Surgery and Diet Group | Response in Glucagon AUC at Baseline vs. Following Gastric Bypass | 32929.1 pg/mL*min |
Primary
Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery
Changes in the glucose Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the glucose AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule.
Time frame: 4-12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet Only Group | Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery | 61647.0 mg/dL*min |
| Surgery and Diet Group | Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery | 59476.1 mg/dL*min |
Primary
Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery
Changes in the Insulin Area Under the Curve (AUC) calculated as the difference between the initial evaluation (test 1, assessed at day 1) and the next evaluation (test 2, assessed at day 9) of study period 1. Subjects then underwent gastric bypass surgery approximately 4-10 weeks later. In study period 2 following surgery, changes in the insulin AUC was again calculated as the difference between the initial evaluation (test 3, assessed at day 1 following surgery) and the next evaluation (test 4, assessed at day 9 following surgery). Change in AUC in study period 1 was compared to change in AUC in study period 2. Blood samples were collected at 5, 10, 15, 20, 25, 30, 40, 50, 60, 80, 100, 120, 150, 180, 210, 240, 300, and 360 minutes after the ingestion of 240 mL of chocolate Boost Plus Nestle. Total AUC was computed using the trapezoidal rule.
Time frame: 4-12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Diet Only Group | Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery | 7888.6 uIU/mL*min |
| Surgery and Diet Group | Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery | 4259.3 uIU/mL*min |