NCT02644590

Brief Summary

Nocturnal hypertension is recognized via ambulatory blood pressure monitoring in adolescents with type 1 diabetes mellitus. Melatonin, (as previously seen in earlier studies in adults), may alter these changes, which may be a benefit especially for patients with diabetes mellitus who are at risk for cardiovascular changes. The purpose of this study is to estimate the use of melatonin as treatment for nocturnal hypertension in young adults with type 1 diabetes melitus.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2016

Shorter than P25 for early_phase_1

Status
unknown

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 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

December 28, 2015

Last Update Submit

December 30, 2015

Conditions

Diabetes Mellitus, Type 1Hypertension

Keywords

MelatoninNocturnal HypertensionType 1 Diabetes Melitus

Outcome Measures

Primary Outcomes (1)

  • blood pressure monitoring , pre and post treatment with melatonin

    4 weeks

Study Arms (1)

Melatonin treatment

EXPERIMENTAL

Adolescents with Type 1 Diabetes will undergo baseline 24 hour ambulatory blood pressure monitoring, followed by treatment with Melatonin for 3 weeks, using a single tablet at bed time, and repeat of the 24-hour blood pressure test following treatment period.

Drug: Melatonin

Interventions

MelatoninDRUG

Detailed in arm description

Also known as: Circadin
Melatonin treatment

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Teenagers and young adults with type 1 diabetes mellitus for at least two years

You may not qualify if:

  • Previously known cardiovascular or renal disease
  • Any previously use of antihypertensive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypertension

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Yonatan Yeshayahu, MD, MHA

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirly Frizinsky, MD

CONTACT

shirly.frizinsky@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 1, 2016

Study Start

February 1, 2016

Primary Completion

September 1, 2016

Study Completion

February 1, 2017

Last Updated

January 1, 2016

Record last verified: 2015-12