DelfaGLP-1 Atlas

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WithdrawnPhase 4

The Effects of Exenatide on Post-Meal Sugar Peaks and Vascular Health in Obese/Pre-Diabetic Young Adults

The Effects of Exenatide on Post-Prandial Glucose Excursions and Vascular Health in Obese/Pre-Diabetic Young Adults

Lead sponsor

Yale University

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

—

Enrollment

—

actual

Study population

Healthy volunteers, Obesity / overweight, Prediabetes / glucose intolerance

Key I/E criterion

•BMI ≥97

Primary endpoint

•Postprandial glucose

Identifiers

Registered as

NCT IDNCT00845559
Org study ID0801003390

Timeline

Milestones

Study first posted2009-02-18estimated
Last update posted2012-12-11estimated
Study start2008-08 (month precision)
Primary completion2010-03estimated (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age13 Years
Maximum age25 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Obese subjects:

Major Inclusion Criteria:

•Obesity (BMI > 97%tile for age and sex matched normative data)
•Insulin resistance: fasting insulin> 25 mIU/ml
•Good general health, taking no medication on a chronic basis
•Age 16-25 yrs, late pubertal stage (girls: breast: Tanner stage IV to V, boys: testicular volume > 15 ml) or age 13-15 yrs (with a family history of type 2 diabetes, whom have completed or reached tanner stage III and have impaired oral glucose tolerance with a 2-hour glucose of 180-199 mg/dl)
•Girls who are sexually active must use adequate birth control methods (such as barrier method or oral contraception) and must have a negative pregnancy test
•Normal liver function tests

Major Exclusion Criteria:

•Hx of gallstones
•Elevated triglycerides >400 mg/dl
•Hx of alcohol use/ binge drinking
•Raynaud's syndrome
•Pregnancy or breastfeeding mothers
•Cigarette smokers
•Anemia (Hct < 35)
•Baseline creatinine > 1.0 mg
•Abnormal liver transaminases > 2.0 X the upper limit of normal
•Presence of endocrinopathies except for adequately treated hypothyroidism
•Presence or history of gastrointestinal disorders (inflammatory bowl disease, irritable bowl disease, hernia, ileus)
•Presence of significant chronic illness of any kind.
•Use of any drugs that might be expected to affect glucose tolerance, insulin resistance or weight gain, cardiovascular health.
•Psychiatric disorders
•History of substance abuse

Lean Control Subjects (only for cardiovascular studies and CGMS):

Inclusion Criteria:

•Lean (BMI < 85%tile for age and sex matched normative data)
•Fasting insulin <15 mIU/m
•Fasting glucose <100 mg/dll
•Excellent general health, having no acute or chronic health problems and taking no current medications
•Age 13-25 yrs, in puberty (age matched with obese subjects)
•Girls who are sexually active must use adequate birth control methods (such as barrier method or oral contraception) and must have a negative pregnancy test

Exclusion criteria

•Raynaud's syndrome
•Pregnancy or breastfeeding mothers
•Cigarette smokers
•Psychiatric disorders
•History of substance abuse
•First degree relative with either T1DM or T2DM
•Presence of acanthosis nigricans

Endpoints (3)

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

Weight & body composition
1
Glycemic / diabetes
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body mass index (BMI).

Time frame:Pre-intervention, 2-month and post-intervention.

BMI, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Whether treatment with exenatide attenuates post-prandial glycemic excursions as assessed by oral glucose tolerance testing (OGTT) and continuous monitoring system (CGMS) technology.

Time frame:OGTT (Pre- and post-intervention), CGMS (Pre-intervention, 2-months and post-intervention)

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint/low confidence

Cardiovascular risk parameters will be assessed via flow mediated vasodilation, peripheral arterial tonometry, a self-paced step test and biochemical markers of vascular health.

Time frame:Pre- (baseline) and post- (4-months) intervention

change from baseline, improvement

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.