Adipokines in Obese Adolescents With Insulin Resistance

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410604
• Other study ID #: 010-08
• Status: Completed
• Phase: Phase 4
• First received: August 4, 2011
• Last updated: April 23, 2012
• Start date: January 2007
• Est. completion date: March 2010

Study information

• Verified date: April 2012
• Source: Hospital Regional de Alta Especialidad del Bajio
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Drug:
• Metformin
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
• Placebo
Tablet of 500 mg oral placebo every 12 hours for 3 months.

Locations

Country	Name	City	State
Mexico	Hospital Regional de Alta Especialidad del Bajío	León	Guanajuato
Mexico	Hospital Infantil de México Federico Gómez	México	Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Regional de Alta Especialidad del Bajio	Hospital Infantil de Mexico Federico Gomez

Country where clinical trial is conducted

Mexico, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adiponectin	Change from baseline in Adiponectin after 3 months of treatment.	baseline and 3 months	Yes
Primary	High-sensitivity C-reactive Protein	Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.	baseline and 3 months	Yes
Primary	Interleukin 6	Change from baseline in Interleukin 6 after 3 months of treatment.	baseline and 3 months	Yes
Primary	Tumour Necrosis Factor Alpha	Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.	baseline and 3 months	Yes
Secondary	Fasting Plasma Glucose	Change from baseline in Fasting plasma glucose after 3 months of treatment.	baseline and 3 months	Yes
Secondary	Fasting Insulin	Change from baseline in Fasting insulin after 3 months of treatment.	baseline and 3 months	Yes
Secondary	Body Mass Index	Change from baseline in Body Mass Index after 3 months of treatment.	baseline and 3 months	Yes
Secondary	Waist Circumference	Change from baseline in Waist circumference after 3 months of treatment.	baseline and 3 months	Yes