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Clinical Trials/NCT03225209
NCT03225209
Completed
Phase 2

Medically Reproducing Bariatric Surgery

Moahad S Dar1 site in 1 country5 target enrollmentJanuary 31, 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Moahad S Dar
Enrollment
5
Locations
1
Primary Endpoint
Change in Glycemic control
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Type 2 diabetes (DM2) is a chronic disease affecting 29 million Americans and a leading cause of blindness, kidney failure, and limb loss (Engelgau et al 2004). Roux-en-Y gastric bypass (RYGB) is the only intervention that leads to durable DM2 remission ~ 80% of the time (Mingrone et al 2012). Yet, it's broad application is limited by cost, invasiveness, and clinical inertia. Medically reproducing RYGB would extend the benefit of disease remission to the vast majority of DM2 patients using a cheaper, less invasive and more palatable treatment approach. Although all of the mechanisms mediating DM2 remission are not known, it is widely accepted that RYGB induces caloric restriction and enhances meal-stimulated release of a gut-peptide called glucagon-like-peptide-1 (GLP-1) both of which improve glycemic control in type 2 diabetes (Dar et al 2012; Jackness 2013). Caloric restriction can be achieved using OPTIFAST which is a commercially available medical weight loss program that has demonstrated the ability to decrease weight and improve glycemic control (Kirschner et al; 1998). Enhanced meal-stimulated GLP-1 release can be achieved using Liraglutide an FDA-approved once daily GLP-1 analogue that improves glycemic control and induces weight loss.

The investigators hypothesize that adding OPTIFAST (caloric restriction) in suboptimally controlled DM2 patients on Liraglutide (enhanced meal stimulated GLP-1 release), Metformin and Lantus insulin will medically reproduce RYGB and lead to DM2 remission, weight loss, decreased medication intensity and improved health related quality of life.

Detailed Description

This is a 24 week "proof of concept" study that will examine if adding "caloric restriction" (OPTIFAST) to "enhanced GLP-1 release" (Liraglutide) will lead to discontinuation of Lantus and Metformin. The primary outcome measure is change in glycemic control measured as hemoglobin A1C. Secondary outcome measures are change in weight, medication intensity and health related quality of life.

Registry
clinicaltrials.gov
Start Date
January 31, 2018
End Date
October 23, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Moahad S Dar
Responsible Party
Sponsor Investigator
Principal Investigator

Moahad S Dar

Principal Investigator

East Carolina University

Eligibility Criteria

Inclusion Criteria

  • male or female
  • age 25-70 years
  • BMI \> 30
  • diagnosis of type 2 diabetes
  • weight stable for 3 months
  • hemoglobin A1C \>7% and \<10%
  • on Liraglutide
  • on Metformin
  • on Lantus
  • interested in losing weight

Exclusion Criteria

  • A1C \<7% or \>10%
  • current use of prandial insulin
  • current use of sulfonylurea or any other oral agent except for Metformin
  • current sue of any other basal insulin except for Lantus
  • breast feeding
  • prior history of pancreatitis
  • prior history of gastroparesis
  • history of thyroid cancer/multiple endocrine neoplasia/thyroid nodules/medullary thyroid cancer
  • history of gallstones
  • history of hyperoxaluria or calcium oxalate nephrolithiasis

Outcomes

Primary Outcomes

Change in Glycemic control

Time Frame: Change in HbA1c from baseline at week 12 and week 24 will be measured

Hemoglobin A1C (HbA1C) will be used to assess glycemic control during the study

Secondary Outcomes

  • Change in Weight(Change in weight in kilograms from baseline at week 12 and week 24 will be measured)
  • Change in Medication intensity(Change in MES from baseline at week 12 and week 24 will be measured)
  • Change in Health Related Quality of Life (HRQOL)(Change in PAID from baseline at week 12, and week 24 will be measured)
  • Change in Health Related Quality of Life(Change in EQ-5D-5L from baseline at week 12 and week 24 will be measured)
  • Change in Physical activity(Change in IPAQ from baseline at week 12 and week 24 will be measured)

Study Sites (1)

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