NCT05407831

Brief Summary

Systematic assessment of perinatal, behavioral and genetic risk factors will be evaluated in an underserved population with lean diabetes (LDM) as compared to a control population with obese type 2 diabetes (ODM).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2023

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

June 2, 2022

Last Update Submit

July 24, 2024

Conditions

Lean Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HOMA Index and Beta cell function

    Single visit study

Secondary Outcomes (3)

  • Prevalence of high risk behaviors

    Single visit study

  • Prevalence of perinatal malnutrition

    Single visit study

  • MODY probability >25%

    Single visit study

Study Arms (2)

LDM

Lean Diabetes Mellitus

Genetic: GeneticBehavioral: Social habitsOther: Perinatal stress

ODM

Obese Diabetes Mellitus

Genetic: GeneticBehavioral: Social habitsOther: Perinatal stress

Interventions

GeneticGENETIC

Calculate MODY probability

LDMODM
Social habitsBEHAVIORAL

Alcohol vs Smoking vs Drug use

LDMODM
Perinatal stressOTHER

Survey

LDMODM

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

35 adults with LDM (BMI \<25) will be compared to age, gender and duration of diabetes matched control population of 35 ODM (BMI \>30) adults recruited from the CCH outpatient clinics.

You may not qualify if:

  • individuals \<20 years of age, currently pregnant or undergoing chemotherapy, those on glucocorticoid therapy; history of bariatric surgery or pancreatitis; known positive antipancreatic antibodies; individuals with a BMI between 25.0-29.9, A1c \>10%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cook County Health

Chicago, Illinois, 60612, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva collection

0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

March 15, 2022

Primary Completion

July 26, 2023

Study Completion

July 26, 2023

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)