Pioglitazone and Metformin in Diabetic Children

NCT01396564 | Completed Phase 1

• 1 other identifier: 2005-3606-0003
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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 \<0.05.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Resistin; Inflammation; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Short-term comparison of metformin and pioglitazone in pediatric patients with T2D

  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.

  48 weeks

Secondary Outcomes (1)

• Comparison of long-term effects of metformin vs pioglitazone

  10 years

Study Arms (2)

Metformin

ACTIVE COMPARATOR

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

Pioglitazone

ACTIVE COMPARATOR

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

Interventions

Metformin DRUG

850 mg of Metformin daily, increased to 1700 mg after 12 weeks, for the duration of the trial.

Also known as: Recommended diet and 30 minutes of exercise daily

Metformin

Pioglitazone DRUG

15 mg of pioglitazone daily, increased to 60 mg after 12 weeks.

Also known as: Recommended diet and 30 minutes of exercise daily

Pioglitazone

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Endocrine Outpatient Clinic of the Hospital de Pediatria del CMN "Siglo XXI"

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation; Insulin Resistance

Interventions

Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Niels H Wachter, DMSC

  Supervisor Clinical Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 19, 2011
• Study Start: October 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: July 1, 2011
• Last Updated: July 19, 2011

Record last verified: 2005-01

Locations

ME (1)