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

Dasman Diabetes Institute

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: AphoelineBrake

Study type

Interventional

Funder types

Other

Identifiers

NCT02791867

RA 2014-019

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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™