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Diabetes and Gastric By- Pass

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ClinicalTrials.gov Identifier: NCT01153516
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : March 7, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center

Study Type Observational
Study Design Observational Model: Case-Crossover;   Time Perspective: Prospective
Condition Type 2 Diabetes
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diet Only Group Surgery and Diet Group
Hide Arm/Group Description Patients on diet and activity protocol typical for patients after bariatric surgery Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
Period Title: Overall Study
Started 12 10
Completed 10 10
Not Completed 2 0
Reason Not Completed
Both subjects refused surgery             2             0
Arm/Group Title Diet Only Group Surgery and Diet Group Total
Hide Arm/Group Description Patients on diet and activity protocol typical for patients after bariatric surgery Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery. Total of all reporting groups
Overall Number of Baseline Participants 12 10 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  83.3%
8
  80.0%
18
  81.8%
>=65 years
2
  16.7%
2
  20.0%
4
  18.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 10 participants 22 participants
53.7  (8.1) 53.2  (8.4) 53.7  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
Female
9
  75.0%
7
  70.0%
16
  72.7%
Male
3
  25.0%
3
  30.0%
6
  27.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 10 participants 22 participants
12
 100.0%
10
 100.0%
22
 100.0%
1.Primary Outcome
Title Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diet Only Group Surgery and Diet Group
Hide Arm/Group Description:
Patients on diet and activity protocol typical for patients after bariatric surgery
Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
Overall Number of Participants Analyzed 10 10
Mean (95% Confidence Interval)
Unit of Measure: mg/dL*min
61647.0
(47023.3 to 76270.8)
59476.1
(47943.8 to 71008.4)
2.Primary Outcome
Title Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diet Only Group Surgery and Diet Group
Hide Arm/Group Description:
Patients on diet and activity protocol typical for patients after bariatric surgery
Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
Overall Number of Participants Analyzed 10 10
Mean (95% Confidence Interval)
Unit of Measure: uIU/mL*min
7888.6
(5505.19 to 10272.08)
4259.3
(3262.1 to 5256.4)
3.Primary Outcome
Title Response in Glucagon AUC at Baseline vs. Following Gastric Bypass
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diet Only Group Surgery and Diet Group
Hide Arm/Group Description:
Patients on diet and activity protocol typical for patients after bariatric surgery
Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
Overall Number of Participants Analyzed 10 10
Mean (95% Confidence Interval)
Unit of Measure: pg/mL*min
24332.8
(20624.3 to 28041.3)
32929.1
(25920.5 to 39937.8)
Time Frame 18 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diet Only Group Surgery and Diet Group
Hide Arm/Group Description Patients on diet and activity protocol typical for patients after bariatric surgery Patients on diet and activity protocol typical for patients after bariatric surgery followed by Roux-en-Y gastric bypass surgery.
All-Cause Mortality
Diet Only Group Surgery and Diet Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Diet Only Group Surgery and Diet Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Diet Only Group Surgery and Diet Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      0/10 (0.00%)    
Gastrointestinal disorders     
Nausea   1/12 (8.33%)  1 0/10 (0.00%)  0
Vomiting   1/12 (8.33%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ildiko Lingvay
Organization: University of Texas Southwestern at Dallas
Phone: 214-648-2779
EMail: ildiko.lingvay@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Ildiko Lingvay, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01153516    
Other Study ID Numbers: 122009-049
First Submitted: June 24, 2010
First Posted: June 30, 2010
Results First Submitted: August 2, 2017
Results First Posted: March 7, 2019
Last Update Posted: March 27, 2019