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

NCT ID: NCT02791867

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-07-31

Brief 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

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Active

AphoelineBrake administration

Group Type: ACTIVE_COMPARATOR

AphoelineBrake

Intervention Type: DRUG

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.

Placebo

Placebo Administration

Group Type: PLACEBO_COMPARATOR

AphoelineBrake

Intervention Type: DRUG

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.

Interventions

AphoelineBrake

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.

Intervention Type: DRUG

Eligibility Criteria

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

• 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™

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University at Buffalo

OTHER

Sponsor Role: collaborator

Dasman Diabetes Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadia Zghoul, PhD

Role: PRINCIPAL_INVESTIGATOR

Dasman Diabetes Institute

Jerome Schentag, PharmD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo, New York

Locations

Dasman DIabetes Institute

Kuwait City, , Kuwait

Countries

Kuwait

Other Identifiers

RA 2014-019

Identifier Type: -

Identifier Source: org_study_id