Postprandial Fatty Acids and FABP2 in Type 2 Diabetes Mellitus (DM)

Not Applicable

Completed

• Conditions: Dyslipidemia; Type 2 Diabetes Mellitus
• Interventions: Other: sandwich

• Registration Number: NCT00634673
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief 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. 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 Timeline

• Study Start: 2006-06
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-02
• Study First Submitted: 2008-03-06
• Study First Submitted QC: 2008-03-12
• Last Update Submitted: 2008-03-12
• Study First Posted: 2008-03-13
• Last Update Posted: 2008-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Type 2 diabetes
• homozygote to FABP2 polymorphism:TT or AA

Exclusion Criteria

• age >75 years
• glomerular filtration rate <30ml min-1
• with unstable angina or possible infarct or stroke in the last year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TT	sandwich	patients homozygous for Thr54 (TT)
AA	sandwich	patients homozygous for Ala54 (AA)

Primary Outcome Measures

Name	Time	Method
postprandial serum fatty acids	0, 2, 4,6, and 8 hours after meal

Secondary Outcome Measures

Name	Time	Method
serum endothelin serum fibrinogen	0 and 8 hours after meal

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil