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Adipokines in Obese Adolescents With Insulin Resistance

Primary Purpose

Obesity

Status

Completed

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Metformin

Placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring Metformin, Obesity, Insulin resistance, Interleukin six, Adiponectin, High sensitivity C reactive protein., Tumour Necrosis Factor alpha

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Hospital Infantil de México Federico Gómez
Hospital Regional de Alta Especialidad del Bajío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Adiponectin

Change from baseline in Adiponectin after 3 months of treatment.

High-sensitivity C-reactive Protein

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

Interleukin 6

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

Tumour Necrosis Factor Alpha

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

Secondary Outcome Measures

Fasting Plasma Glucose

Change from baseline in Fasting plasma glucose after 3 months of treatment.

Fasting Insulin

Change from baseline in Fasting insulin after 3 months of treatment.

Body Mass Index

Change from baseline in Body Mass Index after 3 months of treatment.

Waist Circumference

Change from baseline in Waist circumference after 3 months of treatment.

Full Information

NCT ID

NCT01410604

First Posted

August 4, 2011

Last Updated

April 23, 2012

Sponsor

Hospital Regional de Alta Especialidad del Bajio

Collaborators

Hospital Infantil de Mexico Federico Gomez

1. Study Identification

Unique Protocol Identification Number

NCT01410604

Brief Title

Adipokines in Obese Adolescents With Insulin Resistance

Official Title

Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Regional de Alta Especialidad del Bajio

Collaborators

Hospital Infantil de Mexico Federico Gomez

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

The increased prevalence of obesity in pediatric patients is a public health problem particularly because of the difficulties involved with changing lifestyles. Current studies of obese children and adolescents show increased insulin resistance (IR) and chronic inflammatory states. These conditions increase the risk of disability and/or premature death. The current treatment schemes for obese children are conservative and are focused on changing their lifestyles (exercise and dietary plans). However, metabolic conditions, such as IR, dyslipidemia, and inflammatory processes, are perpetuated. Metformin is a biguanide that is used for adolescents with diabetes mellitus and polycystic ovarian syndrome. Several clinical trials with metformin for obese pediatric patients have observed decreases in IR, decreases in weight, and improvements in lipid metabolism. Adipose tissue is not only an energy repository, but also plays an immunological role by the secretion of cytokines. Both overweight adults and adolescents show decreases in adiponectin levels and increases in tumor necrosis factor alpha (TNFα) and interleukin 6 (IL-6). IL-6 can stimulate the production of high-sensitivity C-reactive protein (hs-CRP), which is considered to be a risk marker for the development of cardiovascular disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

Dabex

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Adiponectin

Description

Change from baseline in Adiponectin after 3 months of treatment.

Time Frame

baseline and 3 months

Title

High-sensitivity C-reactive Protein

Description

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

Time Frame

baseline and 3 months

Title

Interleukin 6

Description

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

Time Frame

baseline and 3 months

Title

Tumour Necrosis Factor Alpha

Description

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

Time Frame

baseline and 3 months

Secondary Outcome Measure Information:

Title

Fasting Plasma Glucose

Description

Change from baseline in Fasting plasma glucose after 3 months of treatment.

Time Frame

baseline and 3 months

Title

Fasting Insulin

Description

Change from baseline in Fasting insulin after 3 months of treatment.

Time Frame

baseline and 3 months

Title

Body Mass Index

Description

Change from baseline in Body Mass Index after 3 months of treatment.

Time Frame

baseline and 3 months

Title

Waist Circumference

Description

Change from baseline in Waist circumference after 3 months of treatment.

Time Frame

baseline and 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials: