Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding
This study is currently recruiting participants.
Verified June 2012 by East Carolina University
Sponsor:
East Carolina University
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
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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
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 Glucagon-Like Peptide 1 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013