CompletedPhase 4

Improving Beta Cell Function in Mexican American Women With Prediabetes

Lead sponsor

Ohio State University

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

Recruiting sites

Actual enrollment

360

Study population

Obesity / overweight, Prediabetes / glucose intolerance

Eligibility highlights

•BMI 30-42•Female

Primary endpoint

•Beta Cell Function

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 IDNCT02488057

Org study ID2014H0478

Timeline

Milestones

Study first posted2015-07-02estimated

Last update posted2019-08-28actual

Study start2016-05 (month precision)

Primary completion2019-03actual (month precision)

Study completion2019-03actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all Liraglutide

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Who can enroll

Minimum age18 Years

Maximum age40 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Mexican-american

•Female

•BMI 30-42

•willingness to complete protocol

•pre-diabetic

•English or Spanish literate

Exclusion criteria

•pregnant

•30 min or more of moderate to vigorous activity more than 3 times per week

•cardiovascular disease

•physical limitations that might be aggravated by moderate physical activity

•planning to move in next 12-24 months

•diabetic

Endpoints (8)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Waist Circumference

Time frame:3 months

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint/low confidence

Beta Cell Function

Time frame:3 months

change from baseline, improvement

Secondary/protocol endpoint

Fasting Glucose

Time frame:3 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Triglycerides

Time frame:3 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

HDL cholesterol

Time frame:3 months

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Blood Pressure

Time frame:3 months

change from baseline, improvement

Secondary/protocol endpoint

Heart Sensitive C-reactive protein

Time frame:3 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Presence of genetic polymorphisms

Time frame:3 months

categorical status, descriptive

Publications (10)

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

Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial.
Archives of internal medicine2010 Sep 27PMID20876408doi:10.1001/archinternmed.2010.334via CT.gov background
Combined influence of LDLR and HMGCR sequence variation on lipid-lowering response to simvastatin.
Arteriosclerosis, thrombosis, and vascular biology2010 Jul (month)PMID20413733doi:10.1161/ATVBAHA.110.203273via CT.gov background
Prediabetes: the importance of early identification and intervention.
Postgraduate medicine2010 Jul (month)PMID20675976doi:10.3810/pgm.2010.07.2180via CT.gov background
Relationship between beta-cell mass and diabetes onset.
Diabetes, obesity & metabolism2008 Nov (month)PMID18834430doi:10.1111/j.1463-1326.2008.00939.xvia CT.gov background
Weight loss therapy improves pancreatic endocrine function in obese older adults.
Obesity (Silver Spring, Md.)2008 Jun (month)PMID18388888doi:10.1038/oby.2008.226via CT.gov background
Variation in the 3-hydroxyl-3-methylglutaryl coenzyme a reductase gene is associated with racial differences in low-density lipoprotein cholesterol response to simvastatin treatment.
Circulation2008 Mar 25PMID18332269doi:10.1161/CIRCULATIONAHA.107.708388via CT.gov background
Effects of the long-acting human glucagon-like peptide-1 analog liraglutide on beta-cell function in normal living conditions.
Diabetes care2007 Aug (month)PMID17468345doi:10.2337/dc07-0310via CT.gov background
Haplotypes in the lipoprotein lipase gene influence high-density lipoprotein cholesterol response to statin therapy and progression of atherosclerosis in coronary artery bypass grafts.
The pharmacogenomics journal2007 Feb (month)PMID16755277doi:10.1038/sj.tpj.6500402via CT.gov background
One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes.
Diabetes2004 May (month)PMID15111485doi:10.2337/diabetes.53.5.1187via CT.gov background
Accurate assessment of beta-cell function: the hyperbolic correction.
Diabetes2002 Feb (month)PMID11815482doi:10.2337/diabetes.51.2007.s212via CT.gov background

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.