Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for CVD Among Obese Adolescents

NCT00889876 | Terminated DMC

• 1 other identifier: 2008-000461-28
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to, among obese adolescents, study impact of regular physical activity or metformin therapy on nocturnal blood pressure and related cardiovascular disease risk factors.

Conditions

Cardiovascular Diseases

Keywords

Obesity; Adolescents; Nocturnal blood pressure reduction; Insulin metabolism; Cardiovascular structure and function; Treatment; Exercise; Metformin; Insulin; Blood glucose; Impaired nocturnal blood pressure reduction

Outcome Measures

Primary Outcomes (1)

• Normalization of nocturnal blood pressure dipping

  Before and 3, 6 and 12 months of intervention

Secondary Outcomes (1)

• Normalization of insulin metabolism and cardiovascular structure and function

  Before and 3, 6 and 12 months of intervention

Study Arms (2)

Metformin

EXPERIMENTAL

Drug: Metformin group

Exercise

EXPERIMENTAL

Behavioral: Exercise

Interventions

Metformin group DRUG

2000 mg/day for one year

Metformin

Exercise BEHAVIORAL

3 times/week with a personal coach for one year. Endurance training.

Exercise

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Obesity according to gender and age specific BMI (Cole 2000)
• Reduced nocturnal systolic blood pressure fall (\< 10%)
• Signed informed consent by patient and parents

You may not qualify if:

• Cardiovascular disease
• Insulin dependent diabetes mellitus
• Patient on medications that are contraindicated during Metformin treatment
• Pregnancy
• Mental or physical conditions limiting the ability to participate

Sponsors & Collaborators

• Maria Sandberg Westerstahl: lead

Study Sites (1)

Karolinska Institutet, Karolinska University Hospital Huddinge

Stockholm, 141 86, Sweden

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity; Motor Activity; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Claude Marcus, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 4, 2023

Record last verified: 2011-02

Locations

SE (1)