Lean Diabetes Study

Leon Fogelfeld MD

Status

Withdrawn

Conditions

Lean Diabetes Mellitus

Treatments

Behavioral: Social habits

Genetic: Genetic

Other: Perinatal stress

Study type

Observational

Funder types

Other

Identifiers

NCT05407831

19-204

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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%