Status:
COMPLETED
Effects of Triacylglycerol Structure on Gut Hormones and Haemostatic Markers
Lead Sponsor:
Malaysia Palm Oil Board
Collaborating Sponsors:
Universiti Putra Malaysia
Ministry of Health, Malaysia
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief Summary
Type 2 diabetes mellitus (T2DM) is a chronic disorder determined by lifestyle and genes. It is associated with chronic hyperglycaemia along with other metabolic abnormalities. It is also one of the ri...
Detailed Description
Subjects aged between 30 and 60 years old (male and female) with Type 2 diabetes mellitus (T2DM) will be recruited for this study. A randomized, crossover, double-blind study design will be carried ou...
Eligibility Criteria
Inclusion
- Mild T2DM individuals not planned for medical intervention
- 0 mmol/L ≤ fasting glucose ≤ 11.1 mmol/L
- 5% ≤ HbA1c ≤ 9.0%
- Not using antihypertensive, lipid lowering, insulin/glucose modulating medication
- Mild T2DM individuals currently on medical intervention
- Fasting glucose ≤ 11.1 mmol/L
- HbA1c ≤ 9.0%
- Using antihypertensive, lipid lowering or glucose modulating medication
- Malaysian male or female with T2DM aged between 30 to 60 years old
- Not using insulin
- Not having any complications of diabetes
- No medical history of myocardial infarction, angina, thrombosis, stroke or cancer
- Haemoglobin levels for females ≥ 11.5 gm/dl and males ≥ 12.5 gm/dl
- Serum ferritin \> 15 µg/l at commencement of study
Exclusion
- Medical history of myocardial infarction, angina, thrombosis, stroke or cancer
- Underweight (BMI \< 18.5 kg/m²)
- Using insulin
- Total cholesterol \> 7.0 mmol/L
- Abnormal liver function, renal function and haematology
- Hypersensitive towards heparin
- Gastric or lactose intolerance
- Smoker
- Pregnancy and lactating
- Taking alcohol
- Taking alcohol
- Haemoglobin levels for females ≤ 11.5 gm/dl and males ≤ 12.5 gm/dl
- Serum ferritin \< 15 µg/l at commencement of study
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01906359
Start Date
September 1 2012
End Date
March 1 2014
Last Update
October 12 2015
Active Locations (5)
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1
Malaysian Palm Oil Board (MPOB)
Kajang, Selangor, Malaysia, 43000
2
Hulu Langat District Health Office
Kajang, Selangor, Malaysia, 43100
3
Sepang District Health Office
Sepang, Selangor, Malaysia, 43900
4
Universiti Putra Malaysia
Serdang, Selangor, Malaysia, 43400