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Type 2 Diabetes MellitusNCT01906359

Effects of Triacylglycerol Structure on Gut Hormones and Haemostatic Markers

A study testing Native palm olein (IV56), Chemically interesterified palm olein (IV56) and High oleic sunflower oil in people with Type 2 Diabetes Mellitus, run by Malaysia Palm Oil Board at 5 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 risk factors for cardiovascular disease (CVD). Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Native palm olein (IV56), Chemically interesterified palm olein (IV56) and High oleic sunflower oil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
5 sitesMalaysia
Study dates
Sep 2012to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Mild T2DM individuals not planned for medical intervention
  • 7.0 mmol/L ≤ fasting glucose ≤ 11.1 mmol/L
  • 6.5% ≤ 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Malaysia5 sites

  • Malaysian Palm Oil Board (MPOB)

    Kajang, Selangor, 43000

  • Hulu Langat District Health Office

    Kajang, Selangor, 43100

  • Sepang District Health Office

    Sepang, Selangor, 43900

  • Universiti Putra Malaysia

    Serdang, Selangor, 43400

  • Selangor State Health Office

    Shah Alam, Selangor, 40100

Other trials in Malaysia

About this study

Official title: The Acute Effects of Triacylglycerol Structure of Dietary Fats on Gut Hormones and Haemostatic Markers in Subjects With Type 2 Diabetes Mellitus

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 risk factors for cardiovascular disease (CVD). This disease is due to insulin resistance and/or deficiency as well as increased hepatic glucose output. According to the Third National Health and Morbidity Survey (3rd NHMS), the prevalence of T2DM for adults aged 30 years and above is 14.9%, increased by almost 80% from 1996 to 2006. Dietary composition may affect insulin sensitivity, postprandial triacylglycerol concentration and the risk of T2DM. The role of dietary fats in T2DM is of particular interest and has been clinically studied for many decades. The type of fat we ingest every day consists of different types of fatty acids and different degree of saturation, which in turn influence glucose metabolism by altering cell membrane function, enzyme activity, insulin signalling and gene expression. Previous studies demonstrated that interesterification of dietary fat alter postprandial lipaemia. Saturated fat such as palm olein has been reported to display lower postprandial lipaemia after interesterification. Changing the structure of triacylglycerol (TAG) alters the physical properties of dietary fat which affects digestibility, metabolism and atherogenicity. A recent study conducted by Sanders and co-workers demonstrated reduced levels of plasma glucose-dependent insulinotropic polypeptide (GIP) following both the lard and interesterified palm olein (IPO) compared with the palm olein (PO) and high oleic sunflower oil (HOS) diets in healthy subjects. The GIP and glucagon-like peptide-1 (GLP-1) are major players in the modulation of postprandial insulin secretion by the pancreas. Although GIP secretion in response to meals is normal in patients with Type 2 diabetes mellitus (T2DM), GIP induced secretion of insulin is defective in diabetes. This is observed to be predominantly a defective stimulation of the late phase of insulin response (20-120 minutes). The effect of IPO on GIP may be exaggerated in T2DM patients with impaired insulin sensitivity. Hence, IPO may change the concentrations of gut hormones, postprandial lipaemia, insulinaemic response and CVD related haemostatic markers.

Read the 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 out to investigate the acute effects of high fat meals prepared using palm olein (PO), chemically interesterified palm olein (IPO) and high oleic sunflower oil (HOS) (control) on study subjects with T2DM. Study subjects will have to undergo three postprandial challenges, separated by at least one week interval. Fasting blood sample and duplicate baseline blood samples will be taken in the morning of postprandial day. After that, subjects will be asked to consume a test meal consisting a high fat muffin baked using the aforementioned oils and a milkshake within 10 minutes. After meal, venous blood samples will be taken at time-points 15, 30, 60, 90, 120 min, 3 h, 4 h, 5 h, 6 h and post-heparin plasma 5 min and 15 min for analysis. Pulse wave analysis will be conducted to evaluate central blood pressure and arterial stiffness. Meal appreciation will be assessed by utilising visual analogue scale (VAS) before eating, after eating and at each time-point.

Being tested
Native palm olein (IV56), Chemically interesterified palm olein (IV56), High oleic sunflower oil
Keywords
Interesterified fat, Stereospecific number 2, Gut hormones, GIP, Insulin sensitivity, Postprandial lipaemia, Haemostatic markers
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Native palm olein (IV56)Other

    Also called PO

    Test meal consists of a high fat muffin (containing 50 g native palm olein) and a cup of milkshake, to be taken as breakfast for each postprandial study day.

  • Chemically interesterified palm olein (IV56)Other

    Also called IPO

    Test meal consists of a high fat muffin (containing 50 g chemically interesterified palm olein) and a cup of milkshake, to be taken as breakfast for each postprandial study day.

  • High oleic sunflower oilOther

    Also called HOS

    Test meal consists of a high fat muffin (containing 50 g high oleic sunflower oil) and a cup of milkshake, to be taken as breakfast for each postprandial study day.

Study groups in NCT01906359
Study groupRoleWhat they receive
Dietary fat - POExperimentalNative palm olein (IV56)
Receives: Other: Native palm olein (IV56)
Dietary fat - IPOExperimentalChemically interesterified palm olein (IV56)
Receives: Other: Chemically interesterified palm olein (IV56)
Dietary fat - HOSExperimentalHigh oleic sunflower oil
Receives: Other: High oleic sunflower oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-hour postprandial changes from fasting in glucose-dependent insulinotropic polypeptide (GIP)

    To determine the postprandial changes of GIP.

    Measured: 0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour

Secondary outcomes (5)

  1. 6-hour postprandial changes from fasting in gut hormones

    To determine the postprandial changes of ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY) and cholecystokinin (CCK).

    Measured: 0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 h

  2. 6-hour postprandial changes from fasting in insulinaemic response

    To determine the postprandial changes of glucose, insulin, C-peptide and non-esterified fatty acid (NEFA)

    Measured: 0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour

  3. 6-hour postprandial changes from fasting in lipaemia

    To determine the postprandial changes of triacylglycerol (TAG) and apolipoprotein B48 (apoB48).

    To compare lipoprotein lipase (LPL) activity, chylomicron fatty acid composition and plasma fatty acid (PFA) composition across meals.

    Measured: 0, 1, 2, 3, 4, 5, 6 hour for TAG and apoB48; 6 hour postheparin for LPL; pooled 3, 4, 5 hour for chylomicron and PFA

  4. 6-hour postprandial changes from fasting in haemostatic response

    To determine the postprandial changes of factor FVII activation (FVIIa), plasminogen activator inhibitor-1 (PAI-1)and D-dimer.

    To compare pulse wave analysis (PWA) across meals.

    Measured: 0, 2, 4, 6 hour for FVIIa, PAI-1 and D-dimer; 0, 4 hour for PWA

  5. 6-hour changes from fasting hunger rating using visual analogue scale (VAS)

    To determine the changes in hunger rating and food satiety

    Measured: 0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2013
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01906359
Sponsor's protocol ID
A005/11
Other IDs
NMRR-12-146-11363
Status last verified
Oct 2015
First submitted
11 Jul 2013
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Mo SY, Lai OM, Chew BH, Ismail R, Bakar SA, Jabbar NA, Teng KT. Interesterified palm olein lowers postprandial glucose-dependent insulinotropic polypeptide response in type 2 diabetes. Eur J Nutr. 2019 Aug;58(5):1873-1885. doi: 10.1007/s00394-018-1738-6. Epub 2018 Jun 5.

    PubMed 29872922

Questions about this trial

What is this clinical trial studying?

A study testing Native palm olein (IV56), Chemically interesterified palm olein (IV56) and High oleic sunflower oil in people with Type 2 Diabetes Mellitus, run by Malaysia Palm Oil Board at 5 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-hour postprandial changes from fasting in glucose-dependent insulinotropic polypeptide (GIP) (time frame: 0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01906359, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.

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