Activity and Metformin Intervention in Obese Adolescents | NCT00934570

Studies
Activity and Metformin Intervention in Obese Adolescents

NCT00934570

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Completed

Last Update Posted

Oct 4, 2012Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Obesity
Type 2 Diabetes

Interventions

Metformin and standard exercise
Metformin Intensive exercise
Placebo Standard exercise
Intensive exercise

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
15590	Other Identifier	REB

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Jul 6, 2009

First Submission Date that Met QC Criteria

Jul 7, 2009

First Posted Date

Jul 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2012

Last Update Posted Date

Oct 4, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cheryl, Dr Cheril Clarson, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the sustainability of a two-year intervention aimed at improving body mass index (BMI) and metabolic and vascular health in obese youth. The study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. An initial intensive exercise program will also be compared with a standard exercise program.

Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese children and adolescents will be associated with reduced rate of weight gain, improved BMI, body composition, physical activity, physical fitness, insulin sensitivity, blood lipid profiles, adipocytokines and vascular function.

Detailed Description

This study will assess the sustainability of a two-year intervention and the degree of improvement in body mass index (BMI) and reduction in risk factors for type 2 diabetes and diabetes related cardiovascular disease, as well as evaluating the additive effect of metformin (as GlumetzaTM 500 mg Extended Release Tablets) and comparing an initial intensive exercise program with a standard exercise program. The study will recruit obese youth who are at risk for type 2 diabetes and cardiovascular disease.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin, Standard exercise	Active Comparator	Lifestyle intervention with metformin and standard exercise program.	Drug: Metformin and standard exercise
Placebo, Standard exercise	Placebo Comparator	Lifestyle intervention with placebo and standard exercise program	Behavioral: Placebo Standard exercise
Metformin, Intensive exercise	Active Comparator	Lifestyle intervention with metformin and intensive exercise	Drug: Metformin Intensive exercise
Placebo, Intensive exercise	Placebo Comparator	Lifestyle intervention with placebo and intensive exercise program.	Behavioral: Intensive exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin and standard exercise	Drug	Metformin 1500 mg daily for 2 years	Metformin, Standard exercise

Measure	Description	Time Frame
Reduction in BMI		2 years

Measure	Description	Time Frame
Improvement in physical activity		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Obese adolescents defined as BMI greater than the 95th percentile for age and gender
Metformin naive subjects

Exclusion Criteria:

Elevated fasting plasma glucose ≥ 6.0 mmol/L
2 hour plasma glucose ≥ 11.1 mmol/L after a standard glucose load
A1C > 6.0%
Medication other than "over the counter" drugs, oral contraceptive pill or thyroid hormone replacement
Smoking
Pregnancy
Renal insufficiency (serum creatinine > the upper limit of normal)
Hepatic dysfunction (> 1.5 times the upper limit of normal for AST and ALT)
Latex Allergy
Hypersensitivity to metformin or its ingredients
Breast feeding
Subjects with a history of lactic acidosis
Abnormal creatinine clearance
HIV, HBV, and HCV infections
Drug and alcohol abuse
Severe mental disorders
Subjects who are planning radiologic exams involving in i.v. injection of iodinated contract materials
Participation in another clinical trial
Significant history or presence of cardiovascular, pulmonary, gastrointestinal, immunologic, endocrine, neurologic disorders
Malignant diseases
Previous exposure to any pharmaceutical antidiabetic agent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cheril Clarson, MD	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital, London Health Sciences Centre		London	Ontario	N6A 5W9	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27433488	Derived	Clarson CL, Brown HK, De Jesus S, Jackman M, Mahmud FH, Prapavessis H, Robinson T, Shoemaker JK, Watson M, Dowd AJ, Hill DJ. Effects of a Comprehensive, Intensive Lifestyle Intervention Combined with Metformin Extended Release in Obese Adolescents. Int Sch Res Notices. 2014 Nov 10;2014:659410. doi: 10.1155/2014/659410. eCollection 2014.
19943971

ID	Term
D009765	Obesity
D003924	Diabetes Mellitus, Type 2
D009043	Motor Activity

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals