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Delfa

← All trials/NCT03225209

MRB

CompletedPhase 2

Medically Reproducing Bariatric Surgery

Lead sponsor

Moahad S Dar

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

5

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥30•HbA1c 7-10%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. 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

Liraglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

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 6, 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 6, 2026 snapshot.