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

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02791867
• Other study ID #: RA 2014-019
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 2014
• Est. completion date: July 2017

Study information

• Verified date: December 2016
• Source: Dasman Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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™

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Kuwait	Dasman DIabetes Institute	Kuwait

Sponsors (2)

Lead Sponsor	Collaborator
Dasman Diabetes Institute	University at Buffalo

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Insulin Resistance measured by HOMA-IR	Homeostatic model assessment (HOMA) is a method for assessing ß-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin levels.	12 months from intervention
Primary	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	Reduction in serum triglyceride level (mmol/l)		12 months from intervention