DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01588418

CompletedPhase 4Results posted

Acute Effect of Exenatide on Brain Glucose Metabolism

Effect of Exenatide on Brain Glucose Uptake in Relations to Pancreatic, Adipose Tissue, and Hepatic Function

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

15

actual

Study population

Obesity / overweight, Prediabetes / glucose intolerance, Type 2 diabetes

Key I/E criteria

•BMI 25-40•Male

Primary endpoint

•CMRglu

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 IDNCT01588418
Org study ID233-GAS-08

Timeline

Milestones

Study first posted2012-05-01estimated
Results first posted2017-05-25actual
Last update posted2017-11-24actual
Study start2010-07 (month precision)
Primary completion2015-07actual (month precision)
Study completion2015-07actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intoleranceType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

1. Males age 18-65 years old

2. Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2

3. 2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes.

4. Patients must have BMI of 25-40 kg/m2

5. Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study.

6. Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.

7. Patients must have the following laboratory values:

–Hematocrit ≥ 34 vol%
–Serum creatinine* ≤ 1.5 mg/dl in males and
–Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT): ≤ 2.5 times upper limit of normal
–Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT): ≤ 2.5 times upper limit of normal
–Alkaline phosphatase ≤ 2.5 times upper limit of normal
–If serum creatinine is ≤ 1.5 mg/dl in males, the PI can grant an exception and not exclude the patient if the Glomerular filtration rate (GFR) is >70 ml/min

Exclusion criteria

Patients are excluded from participation in the study if they meet any of the following criteria:

1. Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease)

2. Patients with BMI over 40 and under 25

3. Patient with age below 18 yrs and over 65 yrs

4. Female subjects

5. Patients with type 1 diabetes

6. Patients treated for type 2 diabetes

7. Subjects with normal glucose tolerance (NGT)

Endpoints (2)

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

Glycemic / diabetes
1
Cardiometabolic biomarkers
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint/low confidence

Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake

Time frame:60 minutes after exenatide or placebo injection

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Primary/protocol endpoint

Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism

Time frame:120 minutes after exenatide or placebo injection

CMRglu

change from baseline, descriptive

Posted result

GroupValue (mean), μmol/(ml*min)95% CI
Effect of Exenatide or Placebo on CMRglutotal gray matter CMRglu after Exenatide0.14—
total gray matter CMRglu after Placebo0.10—

Publications (2)

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 tableClinicalTrials.gov results section

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.