Clinical trial NCT01597531: Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding
Official title: LIRAGLUTIDE AND ORLISTAT TREATMENT FOR PERSISTENT TYPE 2 DIABETES AFTER GASTRIC BANDING: A PILOT STUDY
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Type 2 Diabetes
Gastric Banding
Keywords: Liraglutide
Orlistat
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2012-05-14
Enrollment: 1
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether addition of 1 or 2 medicines after gastric banding can improve remission of type 2 diabetes.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Subjects will be eligible if they meet the following criteria:

* male or female,
* age 25-70 years,
* BMI 26-65,
* type 2 diabetic,
* weight stable for 3 months,
* status post laparoscopic adjustable gastric banding (LAGB) for at least 1 year,
* hemoglobin a1c 7-10%;
* on any diabetic regimen including insulin except for thiazolidinedione use in the past 6 months.

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

* prior history of pancreatitis,
* prior history of gastroparesis,
* glomerular filtration rate (GFR) \< 50,
* history of thyroid cancer/multiple endocrine neoplasia/thyroid nodules/medullary thyroid cancer,
* history of cholelithiasis,
* history of hyperoxaluria or calcium oxalate nephrolithiasis,
* abnormal AST,
* ALT elevation,
* current or past history of liver disease,
* history of Roux-en-y gastric bypass or gastric sleeve or any other bariatric procedure other than LAGB,
* type 1 diabetes,
* any gastrointestinal disease causing malabsorption (including but not limited to inflammatory bowel disease, celiac sprue),
* prior history of Orlistat or incretin therapy use in past 3 months,
* unwilling or unable to complete scheduled testing,
* thiazolidinedione use within past 6 months,
* any serious and/or unstable medical, psychiatric, or other condition(s) that prevents the patient from providing informed consent or complying with the study.

Patients who have had organ transplantation are on chronic anticoagulation, pregnant or have A1C values \> 10% will also be excluded.

Primary outcomes:
measure: Type 2 diabetes remission
timeFrame: baseline, 1 and 4 months post-randomization
Secondary outcomes:
measure: Whole body insulin sensitivity
timeFrame: baseline, 1 and 4 months post-randomization
measure: GLP-1 response
timeFrame: Baseline, 1 and 4 months post-randomization
measure: First Phase Insulin secretion
timeFrame: Baseline, 1 and 4 months post-randomization
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Brody School of Medicine at East Carolina University
state: North Carolina
Study officials:
References:
citation: Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.