Clinical trial NCT05407831: Lean Diabetes Study
Official title: Lean Diabetes Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lean Diabetes Mellitus
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2022-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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%

Primary outcomes:
measure: HOMA Index and Beta cell function
timeFrame: Single visit study
Secondary outcomes:
measure: Prevalence of high risk behaviors
timeFrame: Single visit study
measure: Prevalence of perinatal malnutrition
timeFrame: Single visit study
measure: MODY probability >25%
timeFrame: Single visit study
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cook County Health
state: Illinois
Study officials:
References: