Lean Diabetes Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lean Diabetes Study

Conditions
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Lean Diabetes Mellitus

Intervention / Treatment
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* Genetic: Genetic
* Behavioral: Social habits
* Other: Perinatal stress


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LDM<br>Lean Diabetes Mellitus | Genetic: Genetic<br>* Calculate MODY probability<br>Behavioral: Social habits<br>* Alcohol vs Smoking vs Drug use<br>Other: Perinatal stress<br>* Survey<br>|
| ODM<br>Obese Diabetes Mellitus | Genetic: Genetic<br>* Calculate MODY probability<br>Behavioral: Social habits<br>* Alcohol vs Smoking vs Drug use<br>Other: Perinatal stress<br>* Survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA Index and Beta cell function |  | Single visit study | 

Secondary Outcome Measures

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