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NCT03225209 · ClinicalTrials.gov registry record · Phase 2

Medically Reproducing Bariatric Surgery

A Phase 2 study of Type 2 Diabetes Mellitus, sponsored by Moahad S Dar.

Completed
Registry status
Phase 2
Development phase
5
Enrollment target
1
Study location

NCT03225209 is a Phase 2 study of Type 2 Diabetes Mellitus that has completed, run by Moahad S Dar. The registered enrollment target is 5 participants, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03225209, a Phase 2 study of Type 2 Diabetes Mellitus, has completed, sponsored by Moahad S Dar.

COMPLETED
Registry status
Phase 2
Development phase
5 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • OTHER OPTIFAST

Study Locations (1)

North Carolina

  • Department of Veteran Affairs, Greenville Health Care Center - Greenville

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2018-01-31
Est. Completion 2018-10-23
Phase Phase 2

Sponsor

Moahad S Dar

1 total trials

What the Registry Record Tells You About NCT03225209

The ClinicalTrials.gov registry entry for NCT03225209 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,748-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (100% lower). The listed sponsor is Moahad S Dar, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which OPTIFAST is the first listed.

NCT03225209 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT03225209 about?

NCT03225209 is a clinical study titled "Medically Reproducing Bariatric Surgery". 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,...

What is the current status of trial NCT03225209?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2018-01-31. Estimated completion is 2018-10-23.

What conditions does trial NCT03225209 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.

What interventions are being tested in trial NCT03225209?

The interventions under investigation include: OPTIFAST (OTHER).

Who is sponsoring clinical trial NCT03225209?

This trial is sponsored by Moahad S Dar, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03225209 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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