NCT01394887

Brief Summary

Hypothesis. To determine the effect of metformin on the concentrations of resistin and other insulin resistance or inflammatory markers (C-reactive protein, cytokines, body weight, HbA1c, among others) in minors with glucose intolerance. Children with glucose intolerance are given either metformin or placebo for 12 consecutive weeks. High sensitivity C-reactive protein, TNF-alpha, IL-6, IL1-beta, resistin, leptin, adiponectin, glucose, insulin, HbA1c, lipid profile and transaminases are measured at the beginning and at the end of the period. Statistical analysis: t Student test; Friedman and Kruskal Wallis test are used. Variables are adjusted for: sex, age, baseline BMI and percentage weight change.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
Last Updated

July 18, 2011

Status Verified

July 1, 2002

Enrollment Period

1 year

First QC Date

July 13, 2011

Last Update Submit

July 15, 2011

Conditions

Glucose IntoleranceInflammationDiabetes

Keywords

Metformin, inflammationresistinimpaired glucose tolerancechildren

Outcome Measures

Primary Outcomes (1)

  • presence of inflammation

    to determine the efficacy of metformin in avoiding deterioration of glucose intolerance to type 2 diabetes, as measured by inflammation through various recognized inflammation markers

    1 year

Secondary Outcomes (1)

  • presence of type 2 diabetes

    10 years

Study Arms (2)

metformin group

ACTIVE COMPARATOR

this group received 850 mg metformin twice daily, along with recommended diet and exercise

Drug: Metformin

placebo group

PLACEBO COMPARATOR

This group received 850 mg of placebo twice daily, along with a recommended regimen of diet and exercise

Drug: placebo

Interventions

MetforminDRUG

850 mg of metformin twice daily over 12 weeks

Also known as: Diet and physical activity
metformin group
placeboDRUG

850 mg gel capsules with starch (6.8 calories)as placebo

Also known as: Diet and physical activity
placebo group

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pediatric patients with glucose intolerance per ADA criteria,
  • free of acute or chronic inflammatory processes 3 months prior to recruitment,
  • years of age

You may not qualify if:

  • previous personal history of diabetes or demonstrating diabetes in OGTT curve,
  • chronic renal disease or serum creatinine over 1.4 mg/dl (females) or 1.5 (males),
  • active hepatic disease,
  • smoking,
  • primary dislipidemia,
  • heart problems,
  • steroids,
  • chronic metabolic acidosis,
  • receiving anti-hypertensive or hypolipemia or hypoglucemia medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (1)

  • Gomez-Diaz RA, Talavera JO, Pool EC, Ortiz-Navarrete FV, Solorzano-Santos F, Mondragon-Gonzalez R, Valladares-Salgado A, Cruz M, Aguilar-Salinas CA, Wacher NH. Metformin decreases plasma resistin concentrations in pediatric patients with impaired glucose tolerance: a placebo-controlled randomized clinical trial. Metabolism. 2012 Sep;61(9):1247-55. doi: 10.1016/j.metabol.2012.02.003. Epub 2012 Mar 17.

    PMID: 22424822DERIVED

MeSH Terms

Conditions

Glucose IntoleranceInflammationDiabetes Mellitus

Interventions

MetforminDietExercise

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Niels H Wacher, MD

    Supervisor Clinical Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 15, 2011

Study Start

July 1, 2002

Primary Completion

July 1, 2003

Study Completion

July 1, 2011

Last Updated

July 18, 2011

Record last verified: 2002-07

Locations

ME(1)