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Pioglitazone and Metformin in Diabetic Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396564
First Posted: July 19, 2011
Last Update Posted: July 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Coordinación de Investigación en Salud, Mexico
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Drug: Metformin Drug: Pioglitazone Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Pioglitazone and Metformin on Resistin Plasma Levels in Children With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Short-term comparison of metformin and pioglitazone in pediatric patients with T2D [ Time Frame: 48 weeks ]
    To compare the effectiveness of metformin vs pioglitazone in children with T2D, in terms of resistin levels and insulin resistance. Compare various markers such as HbA1c,fasting plasma glucose, lipids, and hepatic function.


Secondary Outcome Measures:
  • Comparison of long-term effects of metformin vs pioglitazone [ Time Frame: 10 years ]
    To compare the effectiveness of metformin vs pioglitazone in children with T2D, in terms of resistin levels and insulin resistance. Compare various markers such as HbA1c,fasting plasma glucose, lipids, and hepatic function over the long-term, as well as any secondary effects.


Enrollment: 56
Study Start Date: October 2005
Study Completion Date: July 2011
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin
Randomized patients are given 850 mg of metformin daily, increased to 1700 mg after 12 weeks. Adherence is evaluated and after the first phase, the arm is opened. Fasting plasma glucose concentration, body weight, and blood pressure, fasting plasma lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol), HbA1c are measured during the initial and final week of treatment. Dietary adherence is reinforced.
Drug: Metformin
850 mg of Metformin daily, increased to 1700 mg after 12 weeks, for the duration of the trial.
Other Name: Recommended diet and 30 minutes of exercise daily
Active Comparator: Pioglitazone
Randomized patients are given 15 mg of pioglitazone daily, increased to 60 mg after 12 weeks. Adherence is evaluated and after the first phase, the arm is opened. Fasting plasma glucose concentration, body weight, and blood pressure, fasting plasma lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol), HbA1c are measured during the initial and final week of treatment. Dietary adherence is reinforced.
Drug: Pioglitazone
15 mg of pioglitazone daily, increased to 60 mg after 12 weeks.
Other Name: Recommended diet and 30 minutes of exercise daily

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

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396564


Locations
Mexico
Endocrine Outpatient Clinic of the Hospital de Pediatria del CMN "Siglo XXI"
Mexico City, DF, Mexico, 06720
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Study Director: Niels H Wachter, DMSC Supervisor Clinical Research
  More Information

Responsible Party: Niels Wacher, Head of Research Unit for Clinical Epidemiology
ClinicalTrials.gov Identifier: NCT01396564     History of Changes
Other Study ID Numbers: 2005-3606-0003
First Submitted: July 15, 2011
First Posted: July 19, 2011
Last Update Posted: July 20, 2011
Last Verified: January 2005

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Type 2 diabetes
Resistin
Inflammation
Insulin Resistance

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs