NCT01472341 - Beta-Cell Dysfunction and Insulin Resistance Among Italian Patients With Type 2 Diabetes (MK-0000-113) | Crick

Overview

The purpose of this study is to evaluate the degree of beta-cell dysfunction among participants with type 2 diabetes and the association between beta-cell dysfunction and demographic, clinical, and treatment variables.

Study Type

OBSERVATIONAL

Enrollment

507

Conditions

Type 2 Diabetes

Eligibility

Sex: ALLMin age: 41 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Physician diagnosis of type 2 diabetes mellitus by American Diabetes Association (ADA) criteria * Oral hypoglycemic drug therapy for ≥1 year * Continuous care at the clinic (at least 2 visits) for at least one year * Medical records completed with a minimum core data set * Completed consent form Exclusion Criteria: * Participation in a clinical trial in the previous 1 year * Currently using insulin * Type 1 diabetes * Pregnancy

Outcomes

Primary Outcomes

Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years

HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5.

Time frame: Baseline and 4 years

Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at 4 Years

Proinsulin is the prohormone precursor to insulin made in the beta cells of the islets of Langerhans, specialized regions of the pancreas. A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.

Time frame: Baseline and Year 4

Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) According to Quartiles of Proinsulin/Insulin (PI/I) Ratio

HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.

Time frame: Baseline