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. 2016 Nov 29;2016(11):CD012436. doi: 10.1002/14651858.CD012436

NCT00889876.

Trial name or title Effect of exercise or metformin on nocturnal blood pressure and other risk factors for CVD among obese adolescents
Methods Type of trial: interventional; randomised controlled trial
Allocation: randomised
Intervention model: factorial assignment
Masking: open label
Primary purpose: treatment
Participants Condition: CVDs
Enrolment: 100
Inclusion criteria:
  • aged 13 to 19 years at inclusion date

  • obesity according to sex‐ and age‐specific BMI (Cole 2000)

  • reduced nocturnal systolic blood pressure fall (< 10%)

  • signed informed consent by participant and parents


Exclusion criteria:
  • CVD

  • insulin‐dependent diabetes mellitus

  • participant on medications that are contraindicated during metformin treatment

  • pregnancy

  • mental or physical conditions limiting the ability to participate

Interventions Intervention: metformin
Comparator: exercise
Outcomes Primary outcome:
  • normalisation of nocturnal blood pressure dipping


Secondary outcome:
  • normalisation of insulin metabolism and cardiovascular structure and function

Starting date Trial start date: February 2009
Trial completion date: December 2012 (estimated)
Contact information Responsible party/principal investigator: Professor Claude Marcus, Karolinska Institutet, Karolinska Institute
Study identifier NCT number: NCT00889876
Other trial ID numbers: 2008‐000461‐28
Official title Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for Cardiovascular Disease (CVD) Among Obese Adolescents
Stated purpose of study Quote: "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"
Notes This trial has not been verified on the clinicaltrials.gov website since February 2011. We have attempted to contact the principal investigator via email; however, have not received a response. Trial sponsor: Karolinska Institutet