Trial Outcomes & Findings for Diabetes and Gastric By- Pass (NCT NCT01153516)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

22 participants

Primary outcome timeframe

4-12 weeks

Results posted on

2019-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Diet Only Group Patients on diet and activity protocol typical for patients after bariatric surgery	Surgery and Diet Group Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
Overall Study STARTED	12	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Diet Only Group Patients on diet and activity protocol typical for patients after bariatric surgery	Surgery and Diet Group Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
Overall Study Both subjects refused surgery	2	0

Baseline Characteristics

Diabetes and Gastric By- Pass

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diet Only Group n=12 Participants Patients on diet and activity protocol typical for patients after bariatric surgery	Surgery and Diet Group n=10 Participants Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	53.7 years STANDARD_DEVIATION 8.1 • n=5 Participants	53.2 years STANDARD_DEVIATION 8.4 • n=7 Participants	53.7 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diet Only Group n=10 Participants Patients on diet and activity protocol typical for patients after bariatric surgery	Surgery and Diet Group n=10 Participants Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery	61647.0 mg/dL*min Interval 47023.3 to 76270.8	59476.1 mg/dL*min Interval 47943.8 to 71008.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diet Only Group n=10 Participants Patients on diet and activity protocol typical for patients after bariatric surgery	Surgery and Diet Group n=10 Participants Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery	7888.6 uIU/mL*min Interval 5505.19 to 10272.08	4259.3 uIU/mL*min Interval 3262.1 to 5256.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diet Only Group n=10 Participants Patients on diet and activity protocol typical for patients after bariatric surgery	Surgery and Diet Group n=10 Participants Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
Response in Glucagon AUC at Baseline vs. Following Gastric Bypass	24332.8 pg/mL*min Interval 20624.3 to 28041.3	32929.1 pg/mL*min Interval 25920.5 to 39937.8

Adverse Events

Diet Only Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Surgery and Diet Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diet Only Group n=12 participants at risk Patients on diet and activity protocol typical for patients after bariatric surgery	Surgery and Diet Group n=10 participants at risk Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • 18 days	0.00% 0/10 • 18 days
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • 18 days	0.00% 0/10 • 18 days

Additional Information

Dr. Ildiko Lingvay

University of Texas Southwestern at Dallas

Phone: 214-648-2779

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place