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Lean Diabetes Study

Lean Diabetes Study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05407831
Enrollment
0
Registered
2022-06-07
Start date
2022-03-15
Completion date
2023-07-26
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lean Diabetes Mellitus

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).

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.

Interventions

GENETICGenetic

Calculate MODY probability

BEHAVIORALSocial habits

Alcohol vs Smoking vs Drug use

Survey

Sponsors

Leon Fogelfeld MD
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Cases: BMI \<25 with diabetes, not having

Exclusion criteria

Controls: BMI \>29 with diabetes, not having

Design outcomes

Primary

MeasureTime frame
HOMA Index and Beta cell functionSingle visit study

Secondary

MeasureTime frame
Prevalence of high risk behaviorsSingle visit study
Prevalence of perinatal malnutritionSingle visit study
MODY probability >25%Single visit study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026