DyslipidemiaNCT00634673
Postprandial Fatty Acids and FABP2 in Type 2 Diabetes Mellitus (DM)
A study testing sandwich in people with Dyslipidemia and Type 2 Diabetes Mellitus, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This study will be conducted in type 2 diabetic patient's to evaluate the if there is a different response of serum lipids after a standard meal (rich in saturated fatty acids) in patients who have the presence of a genetic alteration. Read more about this study
- Who is it for?
- Ages 40 weeks to 75 years
- Conditions the study is for
- Dyslipidemia, Type 2 Diabetes Mellitus
- What is being tested?
- sandwich
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2006to Oct 2007
- 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 40 weeks to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetes
- homozygote to FABP2 polymorphism:TT or AA
Who cannot join
- age >75 years
- glomerular filtration rate <30ml min-1
- with unstable angina or possible infarct or stroke in the last year
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: FABP2 Ala54Thr Genotype Influences the Postprandial Serum Fatty Acids Profile in Type 2 Diabetic Patients
This study will be conducted in type 2 diabetic patient's to evaluate the if there is a different response of serum lipids after a standard meal (rich in saturated fatty acids) in patients who have the presence of a genetic alteration. This alteration that will be evaluated is a polymorphism, change of an amino acid in the gene of FABP2. This gene that can influence the absorption of lipids in the intestine and subjects who have the altered genotype (presence of T allele) can have an abnormal lipid profile as compared to subjects without this genotype.
Read the detailed description
Background: The presence of Ala54Thr polymorphism of intestinal fatty acid-binding protein 2 gene (FABP2) might influence the intestinal absorption of dietary fatty acids (FAs) and has been associated with diabetic nephropathy.
Objective: We studied the postprandial serum FAs in type 2 diabetic patients homozygous for Thr54 (TT; n = 11) or for Ala54 (AA; n = 15) after a standard meal.Design: Patients received a sandwich (7.23 kcal/kg-total energy; 43.35% fat, 21.95% protein, and 34.70% carbohydrate) in the morning after 12-h fasting and FAs in chylomicrons (gas chromatograph), plasma glucose, and serum triacylglycerols were measured at 0, 2, 4, 6 and 8 h. Results: TT and AA patients did not differ regarding age (61.6±6.7 vs. 62.0±7.7years), diabetes duration (12.7±6.9 vs. 13.1±5.6years), male proportion (72.7 vs. 86.7%), blood pressure, type of diabetes treatment and previous macronutrients intake as well as serum A1C test (6.5±0.6 vs. 6.7±0.4%), LDL (3.0±1.0 vs. 3.2±0.6mmo/L), HDL (1.3±0.2 vs. 1.3±0.4mmol/L), triacylglycerols [1.6(1.0-3.4) vs. 1.6(0.6-3.7)mmol/L], saturated, monounsaturated, and polyunsaturated FAs, and trans-unsaturated FAs. The increase in serum glucose and triacylglycerols after the meal (ANOVA,P<0.001) was not different in both groups. The maximum increase of FAs occurred at 6-h postprandial, but only in TT patients: saturated FAs increased from 464.4(56.9-1602.5) to 1249.5(214.5-7149.8)mg/dL (P=0.041), monounsaturated FAs from 387.9(30.2-1523.8) to 925.1(344.6-5554.0)mgd/L (P=0.026), polyunsaturated FAs from 258.9(0-1048.5) to 713.1(143.7-7987.6)mg/dL (P=0.021), trans-unsaturated FAs from 18.5(1.9-70.6) to 66.5(5.0-451.7)mg/dL (P=0.023). Conclusion: The presence of the T allele of Ala54Thr polymorphism of FABP2 gene in type 2 diabetic patients increases absorption of dietary FAs, including the trans-unsaturated FAs, and this might turns these patients more susceptible to the effect of diet composition.
- Conditions
- Dyslipidemia, Type 2 Diabetes Mellitus
- Being tested
- sandwich
- Keywords
- Serum Fatty Acids, FABP2 Gene, Polymorphism Ala54Thr
- Medical subject headings
- Dyslipidemias, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sandwichOther
Also called fat meal
standard meal:sandwich (7.23 kcal/kg-total energy; 43.35% fat, 21.95% protein, and 34.70% carbohydrate)
| Study group | Role | What they receive |
|---|---|---|
| TT | Other | patients homozygous for Thr54 (TT) Receives: Other: sandwich |
| AA | Other | patients homozygous for Ala54 (AA) Receives: Other: sandwich |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial serum fatty acids
Measured: 0, 2, 4,6, and 8 hours after meal
Secondary outcomes (1)
serum endothelin serum fibrinogen
Measured: 0 and 8 hours after meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startJun 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Mirela J Azevedo, MD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634673
- Sponsor's protocol ID
- HCPA05060
- Status last verified
- Feb 2008
- First submitted
- 6 Mar 2008
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Almeida JC, Gross JL, Canani LH, Zelmanovitz T, Perassolo MS, Azevedo MJ. The Ala54Thr polymorphism of the FABP2 gene influences the postprandial fatty acids in patients with type 2 diabetes. J Clin Endocrinol Metab. 2010 Aug;95(8):3909-17. doi: 10.1210/jc.2009-2674. Epub 2010 May 19.
PubMed 20484485
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FABP2 Ala54Thr Genotype Influences the Postprandial Serum Fatty Acids Profile in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00634673
- Acronym / sponsor ID
- HCPA05060
- Conditions
- Dyslipidemia, Type 2 Diabetes Mellitus
- Keywords
- Serum Fatty Acids, FABP2 Gene, Polymorphism Ala54Thr
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted in type 2 diabetic patient's to evaluate the if there is a different response of serum lipids after a standard meal (rich in saturated fatty acids) in patients who have the presence of a genetic alteration. This alteration that will be evaluated is a polymorphism, change of an amino acid in the gene of FABP2. This gene that can influence the absorption of lipids in the intestine and subjects who have the altered genotype (presence of T allele) can have an abnormal lipid profile as compared to subjects without this genotype.
Detailed description
Background: The presence of Ala54Thr polymorphism of intestinal fatty acid-binding protein 2 gene (FABP2) might influence the intestinal absorption of dietary fatty acids (FAs) and has been associated with diabetic nephropathy.
Objective: We studied the postprandial serum FAs in type 2 diabetic patients homozygous for Thr54 (TT; n = 11) or for Ala54 (AA; n = 15) after a standard meal.Design: Patients received a sandwich (7.23 kcal/kg-total energy; 43.35% fat, 21.95% protein, and 34.70% carbohydrate) in the morning after 12-h fasting and FAs in chylomicrons (gas chromatograph), plasma glucose, and serum triacylglycerols were measured at 0, 2, 4, 6 and 8 h. Results: TT and AA patients did not differ regarding age (61.6±6.7 vs. 62.0±7.7years), diabetes duration (12.7±6.9 vs. 13.1±5.6years), male proportion (72.7 vs. 86.7%), blood pressure, type of diabetes treatment and previous macronutrients intake as well as serum A1C test (6.5±0.6 vs. 6.7±0.4%), LDL (3.0±1.0 vs. 3.2±0.6mmo/L), HDL (1.3±0.2 vs. 1.3±0.4mmol/L), triacylglycerols [1.6(1.0-3.4) vs. 1.6(0.6-3.7)mmol/L], saturated, monounsaturated, and polyunsaturated FAs, and trans-unsaturated FAs. The increase in serum glucose and triacylglycerols after the meal (ANOVA,P<0.001) was not different in both groups. The maximum increase of FAs occurred at 6-h postprandial, but only in TT patients: saturated FAs increased from 464.4(56.9-1602.5) to 1249.5(214.5-7149.8)mg/dL (P=0.041), monounsaturated FAs from 387.9(30.2-1523.8) to 925.1(344.6-5554.0)mgd/L (P=0.026), polyunsaturated FAs from 258.9(0-1048.5) to 713.1(143.7-7987.6)mg/dL (P=0.021), trans-unsaturated FAs from 18.5(1.9-70.6) to 66.5(5.0-451.7)mg/dL (P=0.023). Conclusion: The presence of the T allele of Ala54Thr polymorphism of FABP2 gene in type 2 diabetic patients increases absorption of dietary FAs, including the trans-unsaturated FAs, and this might turns these patients more susceptible to the effect of diet composition.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TT | Other | Other: sandwichpatients homozygous for Thr54 (TT) |
| AA | Other | Other: sandwichpatients homozygous for Ala54 (AA) |
Who may qualify
- Ages
- 40 weeks to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes
- homozygote to FABP2 polymorphism:TT or AA
Key exclusion criteria (3 listed)
- age >75 years
- glomerular filtration rate <30ml min-1
- with unstable angina or possible infarct or stroke in the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sandwichAlso: fat mealstandard meal:sandwich (7.23 kcal/kg-total energy; 43.35% fat, 21.95% protein, and 34.70% carbohydrate) | Other | AA, TT |
Primary outcome
postprandial serum fatty acids
Time frame: 0, 2, 4,6, and 8 hours after meal
1 secondary outcome
serum endothelin serum fibrinogen
Time frame: 0 and 8 hours after meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2008.
- Derived from this study: PubMed 20484485Almeida JC, Gross JL, Canani LH, Zelmanovitz T, Perassolo MS, Azevedo MJ. The Ala54Thr polymorphism of the FABP2 gene influences the postprandial fatty acids in patients with type 2 diabetes. J Clin Endocrinol Metab. 2010 Aug;95(8):3909-17. doi: 10.1210/jc.2009-2674. Epub 2010 May 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirela J Azevedo, MD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sandwich in people with Dyslipidemia and Type 2 Diabetes Mellitus, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 2 inclusion and 3 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 13 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
postprandial serum fatty acids (time frame: 0, 2, 4,6, and 8 hours after meal). 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 NCT00634673, 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 13 Mar 2008.