Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding
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|ClinicalTrials.gov Identifier: NCT01597531|
Recruitment Status : Terminated (Difficulty recruiting patients)
First Posted : May 14, 2012
Last Update Posted : February 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Gastric Banding||Drug: Liraglutide Drug: Orlistat Drug: Liraglutide + Orlistat||Phase 4|
Liraglutide and Orlistat improve glycemic control by increasing glucagon-like-peptide-1 (GLP-1) response and fat malabsorption, respectively but do not reverse type 2 diabetes. Roux-en-y gastric bypass (RYGB) surgery reverses type 2 diabetes 84% of the time while the less invasive, reversible laparoscopic adjustable gastric banding (LAGB) procedure reverses type 2 diabetes 48% of the time.
Decreased caloric intake occurs after RYGB and LAGB but increased post-prandial GLP-1 response and fat malabsorption only occur after RYGB. Since FDA-approved agents Liraglutide and Orlistat increase GLP-1 response and fat malabsorption, respectively, it is of significant clinical interest to determine if addition of Liraglutide and/or Orlistat can improve type 2 diabetes remission rates in the 52% of patients who have not achieved diabetes reversal after gastric banding.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||LIRAGLUTIDE AND ORLISTAT TREATMENT FOR PERSISTENT TYPE 2 DIABETES AFTER GASTRIC BANDING: A PILOT STUDY|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
|Active Comparator: Liraglutide only||
Liraglutide will be started at 0.6 mg injected subcutaneously daily for 1 week and then increased as tolerated to 1.2 mg and then a 1.8 mg daily.
|Active Comparator: Orlistat only||
Orlistat will be started initially at a dose of 60 mg taken with the evening meal. Additional doses will be added at breakfast or lunch every 1-2 weeks as tolerated. The patient will be advised to skip drug dosing if little or no fat is contained in the meal. Target dose will 60 mg three times a day and the patients will be advised to take a multivitamin 2 hours before or after Orlistat addition to ensure adequate nutrition.
|Active Comparator: Liraglutide + Orlistat||
Drug: Liraglutide + Orlistat
Liraglutide will be started at 0.6 mg injected subcutaneously daily for 1 week and then increased as tolerated to 1.2 mg and then a 1.8 mg daily. Patients not tolerating a higher dose will be allowed to remain on the lower dose as long they tolerate the lower. Following titration of Liraglutide to a maximum tolerated dose, Orlistat will be started initially at a dose of 60 mg taken with evening meal. Additional doses will be added at breakfast or lunch every 1-2 weeks as tolerated. The patient will be advised to skip drug dosing if little or no fat is contained in the meal. Target dose will 60 mg three times a day.
- Type 2 diabetes remission [ Time Frame: baseline, 1 and 4 months post-randomization ]Hemoglobin a1c will be used to assess type 2 diabetes remission.
- Whole body insulin sensitivity [ Time Frame: baseline, 1 and 4 months post-randomization ]Minimal model testing will be used to assess whole body insulin sensitivity.
- GLP-1 response [ Time Frame: Baseline, 1 and 4 months post-randomization ]A mixed meal challenge will be used to assess meal-stimulated GLP-1 response.
- First Phase Insulin secretion [ Time Frame: Baseline, 1 and 4 months post-randomization ]Minimal model testing will be used to assess first phase insulin secretion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597531
|United States, North Carolina|
|Brody School of Medicine at East Carolina University|
|Greenville, North Carolina, United States, 28590|