Recruiting

Sibutramine

Sponsor:

Brooke Army Medical Center

Code:

NCT01023139

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Interventions

Sibutramine

Study Details

Brief summary:

There are few studies that look at sustained weight loss in the adolescent population. This study uses a multidisciplinary approach along with pharmacotherapy (use of Meridia)to motivate and establish behavior changes in adolescents (12-18yo) during the first phase of the study.

The second phase will have those who have lost at least 5% BMI to be randomized into one of two groups. This first group will have no intervention and will be followed at 3 and 6 months to assess for weight loss maintenance. The second group will continue on with monthly behavior modifications and also be evaluated at 3 and 6 months.

The hypothesis proposed is that, 1)there will be sustained weight loss at the end of one year in both arms as compared to baseline BMI, 2) and the arm with the behavioral therapy intervention will be more successful than no intervention at weight loss maintenance.

Conditions

Obesity

Study ID

NCT01023139

Start date

Apr, 2009

Status verified date

Dec, 2009

Completion date

Mar, 2011

Anticipated

Primary completion date

Nov, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age: > or = 12 and < or = 18 years old at the time of screening

  • BMI that is at least more than the U.S. weighted mean of the 95th percentile based on age and sex
  • Willing to lose weight to meet and continue study medication for the 12 month treatment period even if he/she meets personal weight loss goal.
  • Willing to not start any new weight loss products
  • Males or non-pregnant females (pregnancy determined by self-report)
  • Females of childbearing potential if practicing acceptable method of contraception

Exclusion Criteria:

  • Weight loss ≥ 10 pounds in previous 3 months
  • Active gastrointestinal disorders (except GERD) such as peptic ulcer disease, irritable bowel disease, and gallbladder condition (in last 3 months); inflammable bowel disease (Crohn's ulcerative colitis, celiac sprue)
  • At least 2 out of 3 blood pressure readings either systolic or diastolic ≥ 95%ile for height and age or pulse ≥95 beats per minute at initial visit.
  • Drug treated diabetes mellitus or drug treated hypertension
  • Drugs and/or supplements administered for the first time or withdrawn during the past 6 months which have a significant impact on body weight or digestion (see Appendix D)
  • Inability or unwillingness to comply with protocol requirements, i.e. considered to be unfit for study participation, or unable to swallow pills.
  • Unwilling to avoid consumption of alcoholic beverages
  • Smoking or has started a smoking cessation program within the past six months
  • Previous treatment with prescription sibutramine (Meridia®)
  • History of recurrent nephrolithiasis
  • Major psychiatric or eating disorders (i.e., major depressive disorder, bipolar disorder, anorexia nervosa, bulimia or laxative abuse)
  • Kidney, liver, or thyroid disorder
  • Drugs that are contraindicated with concomitant use of sibutramine (Meridia®) within last 4 weeks (See Appendix E)
  • Cardiovascular disease (including arrhythmias, heart failure or congenital heart defect
  • History of bleeding problems, hemophilia
  • History of migraine headaches; seizures; a stroke or mini-stroke
  • History of Pulmonary hypertension
  • Osteopenia or osteoporosis
  • Self-report of current recreational drug use or overused prescription medications
  • History of glaucoma
  • Females who self-report pregnancy

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of care (SOC)

No intervention following phase 1 of the study is done during this 2nd phase. Participants will have their height and weights examined at 3 month and 6 month following end of phase 1. During these two visits, they will receive counseling from the physician regarding food choices and exercise maintenance.

experimental: Continuing Behavioral Therapy (CoBT)

This arm follows the end of the phase 1 which incorporates behavioral therapy, nutrition counseling and pharmacotherapy with Sibutramine while medically supervised. Participants randomized to this arm no longer receive medication and will receive behavioral therapy once a month and then evaluated at 3 months and six months for weight loss maintenance.

Interventions

Sibutramine

During phase 1, sibutramine is given to all participants, 10mg po q day. If they do not meet a change in BMI of at least 2.5%,then the dosage may be increased to 15mg po q day. The main intervention in the study during phase 1 and 2is the behavioral modification

Primary outcome measure

  • % change in BMI z score [ Time Frame: 12 month ]

Central Contacts and Locations

Central contacts

Jorge L Cabrera, MD, Ph.D

210-916-0607jorge.luis.cabrera@us.army.mil

Jeffrey R Livezey, MD

210-916-0615jeffrey.livezey@us.army.mil

Locations

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Jorge L Cabrera, MD, PhD

210-916-0607jorge.luis.cabrera@us.army.mil

Jeffrey R Livezey, MD

210-916-0615jeffrey.livezey@us.army.mil

Principal Investigator:

Jorge L Cabrera, MD, PhD

Wilford Hall Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Jorge L Cabrera, MD, PhD

210-916-0607jorge.luis.cabrera@us.army.mil

Jeffrey R Livezey, MD

210-916-0615jeffrey.livezey@us.army.mil

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Dec 2, 2009

Last verified

Dec, 2009

Keywords

  • Adolescent
  • Obesity
  • Pharmacotherapy
  • Sibutramine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2009-12-02.