Viewing Study NCT01396564



Ignite Creation Date: 2024-05-05 @ 11:41 PM
Last Modification Date: 2024-10-26 @ 10:38 AM
Study NCT ID: NCT01396564
Status: COMPLETED
Last Update Posted: 2011-07-19
First Post: 2011-07-15

Brief Title: Pioglitazone and Metformin in Diabetic Children
Sponsor: Coordinación de Investigación en Salud Mexico
Organization: Coordinación de Investigación en Salud Mexico

Study Overview

Official Title: Comparison of the Effects of Pioglitazone and Metformin on Resistin Plasma Levels in Children With Type 2 Diabetes
Status: COMPLETED
Status Verified Date: 2005-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: HYPOTHESIS Treatment with pioglitazone is more effective in reducing resistin concentrations and insulin resistance than metformin in children with Type 2 Diabetes T2D

MATERIAL AND METHODS Pediatric patients aged 8-17 with T2D as defined by the American Diabetes Association ADA were included not under treatment or who had been treated exclusively with diet and exercise or who only received an anti-diabetic agent as well as those with a history of insulin use who had not applied insulin within 1 month before the initial visit History of T2D hypertension exercise diet age gender and somatometry are recorded A Blood sample is taken to determine HbA1c glucose insulin and resistin

STATISTICAL ANALYSIS The percentual change over 4 weeks is analyzed for concentrations of resistin insulin resistance Changes are noted for weeks 12 24 36 and 48 for resistin concentrations HbA1c and HOMA values Baseline and final values are compared with a paired t test Lineal or logarithmic regression analysis is used to evaluate the relationship between homeostasis model assessment of insulin resistance HOMA-IR and resistin concentrations The statistical significance between variables is determined using ANOVA The effect of confounding variables is analyzed with a test of co-variance analysis Statistical significance is considered as p 005
Detailed Description: At 2 weeks prior to study all subjects meet with a dietician and are instructed to consume a weight-maintaining diet containing 50 carbohydrate 30 fat and 20 protein During the week prior to the start of pioglitazone or metformin treatment all subjects come to the clinic after a 12 hr overnight fast for a clinical examination body weight height waist and hip circumferences and biochemical tests All tests are done between 8 and 10 am A general structured interview is conducted A questionnaire is used to obtain information on demographic and socioeconomic aspects Anthropometric measurements are obtained Body weight is measured on a 140-kg capacity floor scale with the child standing in the center of the scale Height is obtained by use of the floor scales stadiometer with the child standing in the center of the scale Height is measured to the nearest 05 cm Body weight is measured recorded to the nearest 01 Kg Body Mass Index BMI is calculated as weight Kg divided by height m2 Abdominal circumference is measured to the nearest 01 cm at the level of the greatest frontal extension of the abdomen between the bottom of the rib cage and the top of the iliac crest The equipment is regularly calibrated using reference samples provided by the manufacturer Baseline measurement of resistin method and insulin concentration method At the same time blood samples are taken for liver function tests fasting plasma glucose lipids and HbA1c

All studies are performed at 0800 h following a 10-12 h overnight fast Following completion of these studies subjects are randomized to start on pioglitazone or metformin 15 mgday and 850 mg respectively for 4 weeks period subjects return to the Clinical of Pediatric Endocrinology at 0800 h following an overnight fast for measurement of fasting plasma glucose concentration body weight and blood pressure Fasting plasma lipids total cholesterol triglyceride HDL cholesterol and LDL cholesterol are measured Fructosamine HbA1c is measured during the initial and final week of pioglitazone or metformin treatment Dietary adherence is reinforced After 4 weeks of treatment all subjects undergo a measurement of fasting plasma glucose resistin and insulin concentration

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None