NCT02645942

Brief Summary

The investigators designed this intervention to investigate the potential role of L-C in lipid and carbohydrates metabolism (primary outcome) with precision noninvasively measurement of: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary outcome) in OSA patients.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
4.6 years until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

December 29, 2015

Last Update Submit

May 4, 2020

Conditions

Obstructive Sleep Apnea

Keywords

Carnitineplaceborisk factors

Outcome Measures

Primary Outcomes (3)

  • Changes in Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides concentration

    6 months

  • Changes in fasting glucose concentration

    6 months

  • Changes in insulin concentration

    6 months

Secondary Outcomes (4)

  • Changes in central blood pressure

    6 months

  • Changes in pulse wave velocity

    6 months

  • Changes in peripheral arterial stiffness

    6 months

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

L-carnitine 1400 mg daily for 8 weeks

Dietary Supplement: L-carnitine

Placebo group

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

L-carnitineDIETARY_SUPPLEMENT

L-carnitine 1400 mg daily for 8 weeks

Intervention group
PlaceboDIETARY_SUPPLEMENT

Placebo daily for 8 weeks

Placebo group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed OSA classified according to the apnea hypopnea index (AHI) as a mild (5.0-14.9), moderate (15.0-29.9), and severe (≥30.0 events per hour),
  • treatment with Continuous Positive Airway Pressure (CPAP) for at least 6 months before study screening,
  • disturbed lipid metabolism (according to the National Health and Nutrition Examination Survey: LDL-C\>100 mg/dl, or TG\>150 mg/dl) or use of hypolipidemic drugs,
  • disturbed glucose metabolism (Diabetes mellitus or impaired glucose tolerance or impaired fasting glucose) according to American Diabetes Federation or use of hypoglycaemic drugs,
  • willingness to participate in the study,
  • age over 18,
  • continued habitual diet during the study period,
  • performance status ≥ 80 according to Karnofsky score

You may not qualify if:

  • newly diagnosed OSA and individuals treated with CPAP,
  • other than OSA lung dysfunctions,
  • do not use of hypoglycaemic and hypolipidemic drugs,
  • modification of hypolipidemic or hypoglycaemic treatment during the study period,
  • pregnancy or lactation,
  • cancer (excluding curatively treated with no evidence of diseases for 5 years),
  • severe liver and kidney diseases (Aspartate aminotransferase (ASPAT) and alanine aminotransferase (ALAT) \>3 × the upper limit of normal (ULN), Bilirubin \>1.5 × ULN, Creatinine \>1.5 × ULN),
  • known sensitivity to any component of the product,
  • diagnosed CVD (myocardial infarct, stroke, angina pectoris).
  • an active drug or alcohol abuse,
  • legal incompetence,
  • limited legal incompetence,
  • any uncontrolled medical condition that may put studied patients at high risk during study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Paweł Bogdański, Ass Prof, MD

    Poznan University of Medical Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof

Study Record Dates

First Submitted

December 29, 2015

First Posted

January 5, 2016

Study Start

August 1, 2020

Primary Completion

December 1, 2020

Study Completion

February 1, 2021

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share