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

Study Overview
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Brief Summary
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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
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: AphoelineBrake


Participation Criteria
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Eligibility Criteria
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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™

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>AphoelineBrake administration | Drug: AphoelineBrake<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo Administration | Drug: AphoelineBrake<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in serum triglyceride level (mmol/l) |  | 12 months from intervention |