Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
OBSERVATIONAL
2022-03-15
2023-07-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Targeting Beta-cell Failure in Lean Patients With Type 2 Diabetes
NCT04657939
GENETIC VARIABILITY TO GLP1 TREATMENT
NCT06298799
The Effect of Liraglutide on Dietary Lipid Induced Insulin Resistance in Humans
NCT02403284
The Acute Effects of Low-dose TNF-α on Glucose Metabolism and β-cell Function in Humans
NCT01953393
Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States
NCT02987335
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LDM
Lean Diabetes Mellitus
Genetic
Calculate MODY probability
Social habits
Alcohol vs Smoking vs Drug use
Perinatal stress
Survey
ODM
Obese Diabetes Mellitus
Genetic
Calculate MODY probability
Social habits
Alcohol vs Smoking vs Drug use
Perinatal stress
Survey
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Genetic
Calculate MODY probability
Social habits
Alcohol vs Smoking vs Drug use
Perinatal stress
Survey
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Leon Fogelfeld MD
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Leon Fogelfeld MD
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cook County Health
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
19-204
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.