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Delfa

← All trials/NCT01760772

UnknownPhase NA

Effect of GLP-1 on Postprandial Lipid Metabolism

The Role of GLP-1 in Lipid Metabolism in Healthy Subjects and in Subjects After Bariatric Surgery

Lead sponsor

David Dalessio

Asset

Avexitide

Listed sites

1

Recruiting sites

-

Estimated enrollment

42

Study population

-

Eligibility highlights

BMI 25-35Healthy volunteers

Primary endpoint

-

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 IDNCT01760772
Org study ID12-09-20-01

Timeline

Milestones

Study first posted2013-01-04estimated
Last update posted2013-01-04estimated
Study start2013-02 (month precision)
Primary completion2015-02estimated (month precision)
Study completion2015-02estimated (month precision)

Assets

Investigational agents

Who can enroll

Minimum age40 Years
Maximum age60 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Aim 1: Healthy, normolipemic men and postmenopausal women; aged 40-60 years; BMI between 25-35
Aim 2: Men and postmenopausal women after successful vertical sleeve gastrectomy (VSG) surgery and age- and weight-matched non-surgical control men and postmenopausal women; ages between 40-6- years; BMI between 28-35; steady weight for at least 3 months prior to study

Exclusion criteria

Exclusion Criteria for Aim 1:

History or clinical evidence of impaired fasting glucose or diabetes mellitus, myocardial infarction or symptoms of congestive heart failure, history or active liver or renal disease, calculated glomerular filtration rate < 60 mL/min).
History of extreme dyslipidemia (i.e. familial hypercholesterolemia) or Cardiovascular disease (CVD).
Fasting plasma total cholesterol > 200 mg/dL and fasting plasma TGs > 150 mg/dL.
Surgery within 6 months.
Pregnancy or lactation.
Anemia defined as hematocrit < 33%.
History of cancer or anorexia nervosa or GI disorders.
Use of medications that alter insulin sensitivity (i.e. niacin, glucocorticoids, metformin) or lipid metabolism (i.e. statin, niacin, fibrate, ezetimibe).
Plasma HbA1c > 6.0.
Fasting glucose > 110 mg/dL
Electrocardiogram (ECG) abnormalities: evidence of ischemia or arrhythmia.

Exclusion Criteria for Aim 2:

History of CVD.
Fasting plasma total cholesterol > 250 mg/dL and fasting plasma TGs > 300 mg/dL.
Surgical intervention within 6 months.
Anemia defined as hematocrit < 33%.
History of cancer or anorexia nervosa or other major GI disease or surgery.
Use of medications that alter insulin sensitivity (i.e. niacin, glucocorticoids, metformin) or lipid metabolism (i.e. statin, ezetimibe).
HbA1c > 6.0.
Fasting glucose > 110 mg/dL
Electrocardiogram (ECG) abnormalities: evidence of ischemia or arrhythmia.
Significant renal, hepatic or pulmonary disease.

Endpoints (0)

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.

No endpoints recorded for this trial.

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.