Lean Diabetes Study

July 24, 2024 updated by: Leon Fogelfeld MD
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Background:

The prevalence of lean (BMI <25, non-type 1) diabetes (LDM) is not rare; however, the reason why these individuals develop diabetes without traditional risk factors is often not investigated. Since this subset of individuals with diabetes are not overweight, they represent an ideal population to examine the causes of diabetes development without the confounding effect of obesity. Understanding critical risk factors for non-autoimmune causes of beta cell underdevelopment, injury and failure can impact prevention, early detection and even treatment in this population of lean individuals. Guidelines for diabetes management currently mainly targets either type 1 or overweight/obese type 2 diabetes (ODM) with a lack of guidance on how best to personalize work-up and treatment in LDM.

Objective:

Systematic assessment of perinatal, behavioral and genetic risk factors will be evaluated in an underserved population with LDM as compared to a control population with ODM. Understanding why certain lean individuals develop diabetes will potentially elucidate mechanisms that could be masked when obesity is also present.

Study Hypothesis:

LDM patients have more impaired beta cell function than classic ODM. The potential pathogenic drivers for the beta-cell impairment in LDM may involve in-utero/childhood malnutrition, lifestyle insults to beta-cells like alcohol and smoking and specific genetic traits that impair beta cell function.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

Cases: BMI <25 with diabetes, not having exclusion criteria Controls: BMI >29 with diabetes, not having exclusion criteria

Exclusion Criteria:

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LDM
Lean Diabetes Mellitus
Genetic: Genetic
Calculate MODY probability
Behavioral: Social habits
Alcohol vs Smoking vs Drug use
Other: Perinatal stress
Survey
ODM
Obese Diabetes Mellitus
Genetic: Genetic
Calculate MODY probability
Behavioral: Social habits
Alcohol vs Smoking vs Drug use
Other: Perinatal stress
Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HOMA Index and Beta cell function
Time Frame: Single visit study
Single visit study

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of high risk behaviors
Time Frame: Single visit study
Single visit study
Prevalence of perinatal malnutrition
Time Frame: Single visit study
Single visit study
MODY probability >25%
Time Frame: Single visit study
Single visit study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leon Fogelfeld MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

July 26, 2023

Study Completion (Actual)

July 26, 2023

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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