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

• Status: Terminated
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dasman Diabetes Institute
• Collaborator: University at Buffalo

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™