Lean Diabetes Study

Withdrawn

• Conditions: Lean Diabetes Mellitus
• Interventions: Genetic: Genetic; Behavioral: Social habits; Other: Perinatal stress

• Registration Number: NCT05407831
• Lead Sponsor: Leon Fogelfeld MD

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.

Study Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-07
• Primary Completion: 2023-07-26
• Study Completion: 2023-07-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LDM	Social habits	Lean Diabetes Mellitus
LDM	Perinatal stress	Lean Diabetes Mellitus
ODM	Genetic	Obese Diabetes Mellitus
ODM	Social habits	Obese Diabetes Mellitus
ODM	Perinatal stress	Obese Diabetes Mellitus
LDM	Genetic	Lean Diabetes Mellitus

Primary Outcome Measures

Name	Time	Method
HOMA Index and Beta cell function	Single visit study

Secondary Outcome Measures

Name	Time	Method
Prevalence of high risk behaviors	Single visit study
Prevalence of perinatal malnutrition	Single visit study
MODY probability >25%	Single visit study

Trial Locations

Locations (1)

Cook County Health; 🇺🇸 Chicago, Illinois, United States