NCT02027571

Brief Summary

The reasons for the epidemics of diabetes and prediabetes, and why individuals from certain populations suffer at higher rates are not well known. In the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study, nearly 400 African Americans and Caucasians whose parents have type 2 diabetes will undergo repeated testing to determine what factors lead to the occurrence of prediabetes, and whether race still plays a major role in a setting where everyone being studied has one or both parents with diabetes. The PROP-ABC Study also will test the hypothesis that the ability of intensive lifestyle intervention to reverse prediabetes and return people's metabolism back to normal is dependent on how long people have had prediabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2016

Enrollment Period

5 years

First QC Date

January 2, 2014

Last Update Submit

October 10, 2018

Conditions

PrediabetesType 2 DiabetesObesity

Keywords

DiabetesRace/EthnicityOffspring CohortAfrican AmericansPrediabetes ReversalLifestyle InterventionInsulin SensitivityBeta-cell FunctionDiabetes Prevention

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is restoration of normal glucose regulation

    The primary outcome measure is restoration of normal glucose regulation (FPG \<100 mg/dl and 2hrPG \< 140 mg/dl).

    Up to 60 months

Secondary Outcomes (1)

  • Glucose normalization

    Up to 60 months

Other Outcomes (1)

  • Incident prediabetes in observational cohort

    Up to 60 months

Study Arms (1)

Intensive Lifestyle Intervention (ILI)

EXPERIMENTAL

ILI consists of weight loss ( \> 10%); caloric reduction; physical activity (180 min/week); monthly visits for group counseling for 6 months, followed by quarterly visits; and meal replacements.

Behavioral: Intensive Lifestyle Intervention (ILI)

Interventions

Intensive Lifestyle Intervention (ILI)BEHAVIORAL

ILI consists of weight loss ( \> 10%); caloric reduction; physical activity (180 min/week); monthly visits for group counseling for 6 months, followed by quarterly visits; and meal replacements.

Intensive Lifestyle Intervention (ILI)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, University of Tennessee Health Scienc Ctr

Memphis, Tennessee, 38104, United States

Location

Related Publications (10)

  • Dagogo-Jack S, Edeoga C, Ebenibo S, Chapp-Jumbo E; Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) Research Group. Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) study: baseline characteristics of enrolled subjects. J Clin Endocrinol Metab. 2013 Jan;98(1):120-8. doi: 10.1210/jc.2012-2902. Epub 2012 Nov 1.

    PMID: 23118422BACKGROUND

  • Ebenibo S, Edeoga C, Ammons A, Egbuonu N, Dagogo-Jack S; Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) Research Group. Recruitment strategies and yields for the Pathobiology of Prediabetes in a Biracial Cohort: a prospective natural history study of incident dysglycemia. BMC Med Res Methodol. 2013 May 10;13:64. doi: 10.1186/1471-2288-13-64.

    PMID: 23663750BACKGROUND

  • Dagogo-Jack S, Edeoga C, Ebenibo S, Nyenwe E, Wan J; Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) Research Group. Lack of racial disparity in incident prediabetes and glycemic progression among black and white offspring of parents with type 2 diabetes: the pathobiology of prediabetes in a biracial cohort (POP-ABC) study. J Clin Endocrinol Metab. 2014 Jun;99(6):E1078-87. doi: 10.1210/jc.2014-1077. Epub 2014 Mar 14.

    PMID: 24628558BACKGROUND

  • Owei I, Umekwe N, Wan J, Dagogo-Jack S. Plasma lipid levels predict dysglycemia in a biracial cohort of nondiabetic subjects: Potential mechanisms. Exp Biol Med (Maywood). 2016 Nov;241(17):1961-1967. doi: 10.1177/1535370216659946. Epub 2016 Jul 17.

    PMID: 27430991BACKGROUND

  • Nyenwe E, Owei I, Wan J, Dagogo-Jack S. Parental History of Type 2 Diabetes Abrogates Ethnic Disparities in Key Glucoregulatory Indices. J Clin Endocrinol Metab. 2018 Feb 1;103(2):514-522. doi: 10.1210/jc.2017-01895.

    PMID: 29216357BACKGROUND

  • Edeoga C, Owei I, Siwakoti K, Umekwe N, Ceesay F, Wan J, Dagogo-Jack S. Relationships between blood pressure and blood glucose among offspring of parents with type 2 diabetes: Prediction of incident dysglycemia in a biracial cohort. J Diabetes Complications. 2017 Nov;31(11):1580-1586. doi: 10.1016/j.jdiacomp.2017.07.019. Epub 2017 Aug 2.

    PMID: 28890305BACKGROUND

  • Owei I, Umekwe N, Mohamed H, Ebenibo S, Wan J, Dagogo-Jack S. Ethnic Disparities in Endothelial Function and Its Cardiometabolic Correlates: The Pathobiology of Prediabetes in A Biracial Cohort Study. Front Endocrinol (Lausanne). 2018 Mar 13;9:94. doi: 10.3389/fendo.2018.00094. eCollection 2018.

    PMID: 29593654RESULT

  • Owei I, Umekwe N, Provo C, Wan J, Dagogo-Jack S. Insulin-sensitive and insulin-resistant obese and non-obese phenotypes: role in prediction of incident pre-diabetes in a longitudinal biracial cohort. BMJ Open Diabetes Res Care. 2017 Jul 19;5(1):e000415. doi: 10.1136/bmjdrc-2017-000415. eCollection 2017.

    PMID: 28878939RESULT

  • Dagogo-Jack S, Umekwe N, Brewer AA, Owei I, Mupparaju V, Rosenthal R, Wan J. Outcome of lifestyle intervention in relation to duration of pre-diabetes: the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study. BMJ Open Diabetes Res Care. 2022 Mar;10(2):e002748. doi: 10.1136/bmjdrc-2021-002748.

    PMID: 35273012DERIVED

  • Dagogo-Jack S, Brewer AA, Owei I, French L, Umekwe N, Rosenthal R, Wan J. Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study: design of lifestyle intervention. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e000899. doi: 10.1136/bmjdrc-2019-000899.

    PMID: 32527719DERIVED

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2ObesityDiabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinism

Study Officials

  • Samuel Dagogo-Jack, MD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 6, 2014

Study Start

October 1, 2013

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 15, 2018

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Group data will be published after completion of study and analysis of results. Individual participant-level information will not be shared.

Locations

US(1)