← Trials/Trial dossier/NCT01055340

CompletedPhase 1

A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects (MK-0000-159)(COMPLETED)

A Randomized Clinical Trial to Study Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects

Asset

GLP-1 / incretin class catch-all

Listed sites

0

Recruiting sites

Enrollment

12

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

BMI 27-35Male

Primary endpoints

Ambient plasma glucose concentration during the GGIPlasma βOHB + AcAc concentrations

Identifiers

Registered as

NCT IDNCT01055340
Org study ID0000-159
Secondary ID159
Secondary ID2010_506

Timeline

Milestones

Study first posted2010-01-25estimated
Last update posted2015-05-29estimated
Study start2010-04 (month precision)
Primary completion2010-05actual (month precision)
Study completion2010-06actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

Subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests
Subject has a Body Mass Index of ≥27 kg/m^2 and ≤35 kg/m^2 and weighs ≥70 kg at the prestudy (screening) visit
Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
Subject is willing to avoid strenuous physical activity (weight lifting, running, bicycling, etc.) for the duration of the study

Exclusion criteria

Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit
Subject has a history of stroke, chronic seizures, or major neurological disorder
Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
Subject has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, or abdominal pain
Subject has a history of hypertension requiring treatment
Subject has a history of cancer
Subject has history of diabetes, or family history of diabetes mellitus
Subject has a history of hypersensitivity to OXM or hemaccel

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
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Ambient plasma glucose concentration during the GGI

Time frame:Last 160 minutes of OXM/placebo infusion

concentration, descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

plasma βOHB + AcAc concentrations

Time frame:First 300 minutes of OXM/placebo infusion

concentration, descriptive

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 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.