Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by East Carolina University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Moahad S Dar, East Carolina University
ClinicalTrials.gov Identifier:
NCT01597531
First received: May 10, 2012
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Gastric Banding
Drug: Liraglutide
Drug: Orlistat
Drug: Liraglutide + Orlistat
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LIRAGLUTIDE AND ORLISTAT TREATMENT FOR PERSISTENT TYPE 2 DIABETES AFTER GASTRIC BANDING: A PILOT STUDY

Resource links provided by NLM:


Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • Type 2 diabetes remission [ Time Frame: baseline, 1 and 4 months post-randomization ] [ Designated as safety issue: No ]
    Hemoglobin a1c will be used to assess type 2 diabetes remission.


Secondary Outcome Measures:
  • Whole body insulin sensitivity [ Time Frame: baseline, 1 and 4 months post-randomization ] [ Designated as safety issue: No ]
    Minimal model testing will be used to assess whole body insulin sensitivity.

  • GLP-1 response [ Time Frame: Baseline, 1 and 4 months post-randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Minimal model testing will be used to assess first phase insulin secretion.


Estimated Enrollment: 9
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Liraglutide only Drug: Liraglutide
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 Drug: Orlistat
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.

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

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597531

Contacts
Contact: Belinda Turner, MSN, RN, CCRC 252-744-2630 TURNERB@ecu.edu

Locations
United States, North Carolina
Brody School of Medicine at East Carolina University Recruiting
Greenville, North Carolina, United States, 28590
Contact: Belinda Turner, MSN, RN, CCRC    252 744-2630    TURNERB@ecu.edu   
Principal Investigator: Moahad S Dar, MD         
Sponsors and Collaborators
East Carolina University
  More Information

Publications:
Responsible Party: Moahad S Dar, Assistant Professor of Medicine, East Carolina University
ClinicalTrials.gov Identifier: NCT01597531     History of Changes
Other Study ID Numbers: ECDOI-D71
Study First Received: May 10, 2012
Last Updated: June 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by East Carolina University:
Liraglutide
Orlistat

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Orlistat
Liraglutide
Glucagon-Like Peptide 1
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 26, 2014