Clinical trial NCT02532101: Modulating Effects of Oil Palm Phenolics in Uncontrolled Insulin-treated Type 2 Diabetes Mellitus
Official title: Modulating Effects of Oil Palm Phenolics in Uncontrolled Insulin-treated Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Uncontrolled Insulin-treated Type 2 Diabetes Mellitus
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: Malaysia Palm Oil Board
name: Clinical Research Centre, Malaysia
First posted: 2015-08-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Recent studies suggest the potential of polyphenols as a supplementary treatment for diabetes mellitus owing to their biological properties. Polyphenols are natural phytochemical compounds found in fruits and vegetables. The most common group of phenolic compounds in our diet are phenolic acids and flavonoids. The two main classes are hydroxybenzoic acid derivatives and hydroxycinnamic acid derivatives.

The potential efficacy of polyphenols on glucose homeostasis and carbohydrate metabolism is being aggressively investigated in in vitro, animal models and clinical trials. The anti-hyperglycemic property of polyphenols is mainly contributed by the reduction of dietary carbohydrate absorption through intestines, improvement of β-cell function and insulin action, stimulation of insulin secretion, modulation of the enzymes involved in glucose metabolism, anti-oxidative and anti-inflammatory effects.

The key enzymes responsible for the digestion of dietary carbohydrates to glucose are α-glucosidase and α-amylase. One of the most well-known properties of polyphenols especially phenolic acids on carbohydrate metabolism is the inhibition of these enzymes. Some investigations have shown that polyphenols are also able to regulate postprandial glycemia and inhibit the development of glucose intolerance by a facilitated insulin response and increased secretion of glucose-dependent insulinotropic polypeptide (GIP) and glucagonlike polypeptide-1 (GLP-1).

The current study focuses on the glucose-controlling properties of phenolic compounds extracted from oil palm (Elaeis guineensis), a high oil-producing tropical plant that also rich in phytochemicals. The major phenolic components in OPP are identified as caffeoylshikimic acid, protocatechuic acid and p-hydroxybenzoic acid. OPP has been found to exert various positive health effects parallel to the well-established physiological benefits of polyphenols. It has been shown that OPP protects against early type 2 diabetes and encouraging results suggest its role in modulating the development of diabetes. The current study aims to investigate and determine the effects of oil palm phenolics (OPP) on the blood glucose control in patients with uncontrolled insulin treated type 2 diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Blood glucose level
timeFrame: 3 months
Secondary outcomes:
measure: Lipid Profile
timeFrame: 3 months
measure: Insulin Sensitivity
timeFrame: 3 months
measure: Global Assessment of Efficacy
timeFrame: 3 months
measure: Beta Cell Function
timeFrame: 3 months
Other outcomes:
Locations:
city: Seberang Jaya
country: Malaysia
facility: Seberang Jaya Hospital
state: Penang
Study officials:
affiliation: Universiti Sains Malaysia
name: Kah Hay Yuen, PhD
role: PRINCIPAL_INVESTIGATOR
References: