← Trials/Trial dossier/NCT03225209

MRB

CompletedPhase 2

Medically Reproducing Bariatric Surgery

Lead sponsor

Moahad S Dar

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

5

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥30HbA1c 7-10%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03225209
Org study ID02050

Timeline

Milestones

Study first posted2017-07-21actual
Study start2018-01-31actual
Primary completion2018-10-23actual
Study completion2018-10-23actual
Last update posted2020-01-31actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age25 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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
agreeable to regular visits per study protocol
access to telephone and reliable transportation
has a VAMC provider

Exclusion criteria

age >70
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
pregnant
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
AST/ALT > 2 times the upper limit of normal
current or past history of liver disease
history of Roux-en-Y gastric bypass or gastric sleeve or any other bariatric procedure
type 1 diabetes
any gastrointestinal disease causing malabsorption
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
organ transplantation or those on immunosuppressants
chronic anticoagulation
recent myocardial infarction, unstable angina, stroke, coronary artery bypass or transient ischemia attacks in the past 6 months
chronic prednisone use
peptic ulcer disease in past 6 months
acute gastrointestinal disorders
hepatitis
cirrhosis
GFR < 50
deep vein thrombosis in the past 6 months
bone fractures in the past 6 months
lithium use
active malignancy
substance abuse
unstable psychiatric condition
history of suicidal ideation
enrolled in another research study related to diet and/or physical activity

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL
3
Weight & body composition
1
Glycemic / diabetes
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in Weight

Time frame:Change in weight in kilograms from baseline at week 12 and week 24 will be measured

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Change in Glycemic control

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Patient-reported / QoL

3 endpoints
Secondary/protocol endpoint

Change in Health Related Quality of Life (HRQOL)

Time frame:Change in PAID from baseline at week 12, and week 24 will be measured

change from baseline, improvement

Secondary/protocol endpoint

Change in Health Related Quality of Life

Time frame:Change in EQ-5D-5L from baseline at week 12 and week 24 will be measured

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

Change in Physical activity

Time frame:Change in IPAQ from baseline at week 12 and week 24 will be measured

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in Medication intensity

Time frame:Change in MES from baseline at week 12 and week 24 will be measured

change from baseline, descriptive

Publications (6)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.