Adipokines in Obese Adolescents With Insulin Resistance

NCT01410604 | Completed Phase 4 Results

• 1 other identifier: 010-08
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR).

Conditions

Obesity

Keywords

Metformin; Obesity; Insulin resistance; Interleukin six; Adiponectin; High sensitivity C reactive protein.; Tumour Necrosis Factor alpha

Outcome Measures

Primary Outcomes (4)

• Adiponectin

  Change from baseline in Adiponectin after 3 months of treatment.

  baseline and 3 months

• High-sensitivity C-reactive Protein

  Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.

  baseline and 3 months

• Interleukin 6

  Change from baseline in Interleukin 6 after 3 months of treatment.

  baseline and 3 months

• Tumour Necrosis Factor Alpha

  Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.

  baseline and 3 months

Secondary Outcomes (4)

• Fasting Plasma Glucose

  baseline and 3 months

• Fasting Insulin

  baseline and 3 months

• Body Mass Index

  baseline and 3 months

• Waist Circumference

  baseline and 3 months

Study Arms (2)

Metformin

EXPERIMENTAL

Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Tablet of 500 mg oral placebo every 12 hours for 3 months.

Drug: Placebo

Interventions

Metformin DRUG

Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.

Also known as: Dabex

Metformin

Placebo DRUG

Tablet of 500 mg oral placebo every 12 hours for 3 months.

Placebo

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Obesity defined as Body Mass Index (BMI) ≥ percentile 95
• Tanner stage ≥ 2
• Insulin resistance defined as Basal insulin \> 15 µU/mL or Homeostasis Model Assessment index (HOMA) \> 4.5
• Patients' parents signed written consents when they and their adolescent children agreed to enroll

You may not qualify if:

• Glucose intolerance
• Diabetes mellitus (type 1 or 2)
• Anemia (Hb \< 10 g/dL)
• Plasma creatinine \> 1.4 mg/dL
• Abnormal hepatic function
• Any associated Disease (Pulmonary, Infection, Autoimmune Disease)
• History of lactic acidosis

Sponsors & Collaborators

• Hospital Regional de Alta Especialidad del Bajio: lead
• Hospital Infantil de Mexico Federico Gomez: collaborator

Study Sites (2)

Hospital Regional de Alta Especialidad del Bajío

León, Guanajuato, 37670, Mexico

Location

Hospital Infantil de México Federico Gómez

Mexico City, Mexico City, 06720, Mexico

Location

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MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

During the recruitment phase, 83 children who were diagnosed with obesity and acanthosis nigricans were evaluated. Of these, 45 did not have the insulin concentration values (\>15 µU/mL) required to biochemically define Insulin Resistance.

Results Point of Contact

• Title: M.D. Maria L. Evia-Viscarra
• Organization: Hospital Regional de Alta Especialidad del Bajio

evialola@hotmail.com

+52 (477) 267-2000

Study Officials

• Maria L Evia-Viscarra, M.D.

  Hospital Regional de Alta Especialidad del Bajio

  PRINCIPAL INVESTIGATOR

• Edel R Rodea-Montero, Statistician

  Hospital Regional de Alta Especialidad del Bajio

  STUDY CHAIR

• Evelia Apolinar-Jiménez, Nutrition

  Hospital Regional de Alta Especialidad del Bajio

  STUDY CHAIR

• Leticia M García-Morales, M.D.

  Hospital Infantil de Mexico Federico Gomez

  STUDY CHAIR

• Constanza Leaños-Pérez, M.D.

  Hospital Infantil de Mexico Federico Gomez

  STUDY CHAIR

• Mireya Figueroa-Barrón, Chemestry

  Hospital Infantil de Mexico Federico Gomez

  STUDY CHAIR

• Dolores Sánchez-Fierros, Chemestry

  Hospital Infantil de Mexico Federico Gomez

  STUDY CHAIR

• Nathalie Muñoz-Noriega, Nutrition

  Hospital Regional de Alta Especialidad del Bajio

  STUDY CHAIR

• Juan G Reyes-García, M.D.

  Escuela Superior de Medicina del IPN

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrics Endocrinology

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 5, 2011
• Study Start: January 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: April 27, 2012
• Results First Posted: April 23, 2012

Record last verified: 2012-04

Locations

ME (2)