NCT02791867|TerminatedPhase 1/2
Study Stopped
The study drug was not provided resulting in termination for unacceptable delays
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Sponsor study identifier
interventional
48
1 country
1
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)The primary objective is to determine if subjects taking the natural product AphoelineBrake™ in addition to their standard treatment experience differences in metabolic disease control, gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared to patients taking a placebo in addition to their standard treatment. The secondary objective is to study the effect of Aphoeline Brake on oxidative and inflammatory stress markers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
May 12, 2016
Actual (reported)June 7, 2016
Actual (reported)July 2017
Actual (reported)July 2017
Actual (reported)Reduction in Insulin Resistance measured by HOMA-IR
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin levels.
12 months from intervention
Reduction in glycated Haemoglobin measured: HBA1c
HbA1c refers to glycated haemoglobin. It develops when haemoglobin, joins with glucose in the blood.
12 months from intervention
Reduction in serum triglyceride level (mmol/l)
12 months from intervention
AphoelineBrake administration
Placebo Administration
The study is proposed as a placebo controlled randomized controlled trial with an intervention (AphoelineBrake) in addition to their standard treatment in comparison to a standard treatment control arm receiving an identical placebo. Prior to the commencement of any study procedures, participants will document informed consent and acknowledgement of privacy rights. Participants will be seen for initial consenting procedures, initial study procedures, and follow-up procedures at the Dasman Diabetes Institute clinic.Scheduled study visits will occur at Day 0, Day 7, Months: 1, 3, 6, 9, and 12 months in accordance with standards of medical care.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Dasman DIabetes Institute
Kuwait City, Kuwait
Nadia Zghoul, PhD
Dasman Diabetes Institute
Jerome Schentag, PharmD
University at Buffalo, New York
48 participants (actual enrollment reported by the registry).
First Submitted
May 12, 2016
First Posted
June 7, 2016
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)Last Updated
November 27, 2018
Record last verified: 2016-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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