TerminatedNCT02791867Updated Nov 27, 2018

Comparison of Laboratory Changes, Food Intake and Metabolic Profile in Patients With Obesity and Type2 Diabetes Mellitus: Before, During and After Taking AphoelineBrake

A Phase 1/2 interventional study of AphoelineBrake in Diabetes Mellitus, Type 2, sponsored by Dasman Diabetes Institute. Terminated at 1 site in Kuwait. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-11-27.

Sponsored by Dasman Diabetes Institute · Phase 1/2, Interventional, and Basic science

Why this study was terminated

The study drug was not provided resulting in termination for unacceptable delays

Phase: Phase 1/2
Study type: Interventional
Enrollment: 48
Allocation: Randomized
Ages: 21 Years and older
Sex: All

Study summary

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.

Conditions studied

Diabetes Mellitus, Type 2

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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 48 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

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Lead sponsor

Dasman Diabetes Institute is the lead sponsor of 30 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age ≥21 years
Diagnosis of T2DM
Metformin as first line treatment
HbA1c ≥7
Calculated HOMA-IR ≥3.0,
BMI 25-45
Triglyceride level ≥ 2.26 mmol/L

Exclusion criteria

Exclusion Criteria:

Age \<21 years of age
BMI ≤ 25
Pregnant
Subjects on chronic nonsteroidal anti-inflammatory drugs or systemic corticosteroids.
Subjects treated with Liraglutide (Victoza®).
Renal, hepatic or cardiac failure.
Subjects with a significant clinical illness within a month before the first administration of Aphoeline Brake™
Subjects diagnosed with Irritable Bowel Syndrome.
Subjects diagnosed with Ulcerative Colitis or Crohn's disease.
History of significant gastrointestinal disease.
Poor venous access.
Poor likelihood to adhere with study procedures, as documented during the MyFitnessPal procedures prior to use of Aphoeline Brake™

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 48 participants (actual)

Study arms

Active comparator
Active
AphoelineBrake administration
Drug: AphoelineBrake
Placebo comparator
Placebo
Placebo Administration
Drug: AphoelineBrake

Interventions

DrugAphoelineBrake
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.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 12 months from intervention

Secondary outcomes

Reduction in serum triglyceride level (mmol/l)
Time frame: 12 months from intervention

Study locations

1 site

Dasman DIabetes Institute
Kuwait, Kuwait

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02791867
Lead sponsor: Dasman Diabetes Institute
Collaborators: University at Buffalo
Responsible party: Sponsor
First posted: Jun 7, 2016
Start date: Dec 2014
Primary completion: Jul 2017
Completion: Jul 2017
Last update: Nov 27, 2018

Study contacts

Nadia Zghoul, PhD

principal investigator · Dasman Diabetes Institute

Jerome Schentag, PharmD

principal investigator · University at Buffalo, New York

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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