CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Intralipid 20% +1 moredrug
Likely dose
Glucose infusion 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00753142
NCT00753142N/ACompleted

Mechanism Underlying Beta-cell Failure in Obese African Americans With History of Hyperglycemic Crises

Emory University·interventional·Posted Sep 16, 2008·Updated Oct 12, 2018

In Brief

A clinical study evaluating Intralipid 20% and Glucose infusion for Diabetes Mellitus, Type 2. Completed, enrolled 28 participants across 1 site.

Detailed Summary

Obesity is common in African American (AA) patients with newly diagnosed diabetes who present with diabetic ketoacidosis (DKA). Despite the presentation with severe symptoms of insulinopenia and ketoacidosis, clinical and immunogenetic observations indicate that most obese AA patients with DKA have type 2 diabetes. In such patients, previous studies reveal that: a) at presentation, obese AA patients with DKA have markedly decreased pancreatic insulin secretion, lower than in obese non-DKA patients admitted with comparable hyperglycemia, but significantly greater than in lean patients with DKA; b) aggressive diabetic management results in significant improvement in beta-cell function and insulin sensitivity sufficient to allow discontinuation of insulin therapy within 3 months of follow-up. Based on these observations the researchers conclude that similar to obese patients with hyperglycemia, most obese AA with DKA have type 2 diabetes, and that although defects in both insulin secretion and insulin action are present, transient b-cell failure is the primary defect in the development of ketoacidosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2008
Enrollment StartMar 1, 2004
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.8 years ago

Interventions

Intralipid 20%drug

Participants receive a 48-hour infusion with Intralipid at 40 milliliters per hour (mL/hr).

Glucose infusiondrug

Participants receive a glucose infusion consisting of 10% dextrose infused intravenously at a rate of 200 mg/m\^2/min for 20 hours.