Modulating Effects of Oil Palm Phenolics in Uncontrolled Insulin-treated Type 2 Diabetes Mellitus

NCT02532101 | Terminated DMC

• 2 other identifiers: UNIDOPP-21102NMRR-14-565-21102
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression in this spontaneous diabetes model. The present study aims to determine the beneficial effects of Oil Palm Phenolics in uncontrolled insulin treated type 2 diabetic patients.

Conditions

Uncontrolled Insulin-treated Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Blood glucose level

  1. Serum Glycosylated Haemogoblin (\<5.7% indicates healthy, 5.7% - 6.4% indicates prediabetes, \>6.5% indicates diabetes) 2. Plasma glucose level of oral glucose tolerance test (\<7.8 mmol/L indicates healthy, 7.8 mmol/L - 11 mmol/L indicates prediabetes, \>11 mmol/L indicates diabetes) 3. Fasting plasma glucose level (\<5.6 mmol/L indicates healthy, 5.6 mmol/L - 6.9 mmol/L indicates prediabetes, \>6.9 mmol/L indicates diabetes)

  3 months

Secondary Outcomes (4)

• Lipid Profile

  3 months

• Insulin Sensitivity

  3 months

• Global Assessment of Efficacy

  3 months

• Beta Cell Function

  3 months

Study Arms (1)

Oil Palm Phenolics

EXPERIMENTAL

500 mg gallic acid equivalent (GAE), twice daily, 3 months

Dietary Supplement: Oil Palm Phenolics

Interventions

Oil Palm Phenolics DIETARY_SUPPLEMENT

Palm fruit derived phenolics compound

Oil Palm Phenolics

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is currently injecting an insulin dosage of \>= 1.0 unit/kilogram/day.
• Subject has a serum glycosylated haemoglobin (HbA1c) \>= 9.
• Subject has fasting plasma glucose level of more than 7.0 mmol/L and less than 12.0 mmol/L.
• Subjects or his/her legally acceptable representative is willing to provide written informed consent.

You may not qualify if:

• Subject with diabetic ketoacidosis or in coma.
• Subject with terminal cancer.
• Subject with renal failure (serum creatinine more than 200 umol/L).
• Subject with significant liver impairment (liver function test of 5 times more than the upper limit level).
• Subject with severe dementia and psychosis.
• Subject requires of long term corticosteroid treatment for the underlying disease such as connective tissue disorder.
• Subject with hemoglobinopathy or anemia.
• Subject underwent splenectomy or suffered from splenomegaly.
• Subject with chronic substance abuse such as chronic alcoholism or chronic opiate usage.
• Female subject of childbearing potential unless subject underwent bilateral tubal ligation, bilateral oophorectomy or hysterectomy previously.
• Subject or care giver is unable to perform self-monitoring of capillary blood glucose at home.
• Subject who have been included in any other clinical trial within the previous 3 months.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Malaysia Palm Oil Board: collaborator
• Clinical Research Centre, Malaysia: collaborator

Study Sites (1)

Seberang Jaya Hospital

Seberang Jaya, Pulau Pinang, 13700, Malaysia

Location

Study Officials

• Kah Hay Yuen, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dr.

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 25, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)