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

Phase 1

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: AphoelineBrake

• Registration Number: NCT02791867
• Lead Sponsor: Dasman Diabetes Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-07
• Status Verified: 2016-12
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2018-11-26
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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™

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	AphoelineBrake	AphoelineBrake administration
Placebo	AphoelineBrake	Placebo Administration

Primary Outcome Measures

Name	Time	Method
Reduction in Insulin Resistance measured by HOMA-IR	12 months from intervention	Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin levels.
Reduction in glycated Haemoglobin measured: HBA1c	12 months from intervention	HbA1c refers to glycated haemoglobin. It develops when haemoglobin, joins with glucose in the blood.

Secondary Outcome Measures

Name	Time	Method
Reduction in serum triglyceride level (mmol/l)	12 months from intervention

Trial Locations

Locations (1)

Dasman DIabetes Institute; 🇰🇼 Kuwait, Kuwait