Pioglitazone and Metformin in Diabetic Children
Information source: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Metformin (Drug); Pioglitazone (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Coordinación de Investigación en Salud, Mexico Official(s) and/or principal investigator(s): Niels H Wachter, DMSC, Study Director, Affiliation: Supervisor Clinical Research
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 <0. 05.
Clinical Details
Official title: Comparison of the Effects of Pioglitazone and Metformin on Resistin Plasma Levels in Children With Type 2 Diabetes
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Short-term comparison of metformin and pioglitazone in pediatric patients with T2D
Secondary outcome: Comparison of long-term effects of metformin vs pioglitazone
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 scale's stadiometer, with the child standing
in the center of the scale. Height is measured to the nearest 0. 5 cm. Body weight is
measured recorded to the nearest 0. 1 Kg. Body Mass Index (BMI) is calculated as weight (Kg)
divided by height (m2). Abdominal circumference is measured to the nearest 0. 1 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 08: 00 h following a 10-12 h overnight fast. Following
completion of these studies, subjects are randomized to start on pioglitazone or metformin,
15 mg/day and 850 mg respectively, for 4 weeks period, subjects return to the Clinical of
Pediatric Endocrinology at 08: 00 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.
Eligibility
Minimum age: 8 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Pediatric patients with type 2 diabetes according to ADA.
- Patients who have not previously received anti-diabetic treatment or have been
treated solely with diet and exercise or have received only one anti-diabetic agent,
and who have not applied insulin within 1 month of study start.
- HbA1c between >6. 5% and <10%.
- Stable body weight at least 3 months before study start.
- No intense exercise.
- Free of other infectious, chronic, or acute inflammatory processes in the 3 months
prior to study.
- Previous informed consent signed (both children and parents or guardians).
- Either sex
- 8-17 years old.
Exclusion Criteria:
- Personal history of type 1 diabetes
- Chronic renal failure or serum creatinine over 1. 0 mg/dl.
- Active hepatic disease (ALT and AST 3 times normal)
- Heart conditions
- Acute or chronic metabolic acidosis
- Receiving steroids or insulin
Locations and Contacts
Endocrine Outpatient Clinic of the Hospital de Pediatria del CMN "Siglo XXI", Mexico City, DF 06720, Mexico
Additional Information
Starting date: October 2005
Last updated: July 18, 2011
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