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Report for Clinical Trial NCT01274091

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Gene-diet Interactions

Interactions between genes and environment, i.e. our inherited responses to environmental changes, may be crucial in the development of the common diseases. The investigators were the first to identify PPARG gene as risk gene for type 2 diabetes. The role of the Pro12Ala polymorphism in diabetes risk has also been verified in meta-analysis. However, this effect on seems to depend on intervention and age. In this study the effects of diets high with saturated fatty acids (SAFA) and polyunsaturated fatty acids (PUFA) are compared in subjects carrying either Pro12Pro or Ala12Ala genotype of the PPARG gene. Aim of the study: To test if subjects with Pro12Pro and Ala12Ala genotypes respond differentially to a diet supplemented with high saturated (SAFA) or polyunsaturated fat (PUFA). Hypotheses: 1. Specific: Subjects with the Ala12Ala genotype will be more sensitive to dietary modification, and therefore respond more favorably to PUFA diet 2. More general: Dietary instructions individually tailored according to the genotype would allow better treatment of obesity and diabetes

NCT01274091 Insulin Sensitivity
MeSH: Insulin Resistance Hypersensitivity
HPO: Allergy Insulin resistance

2 Interventions

Name: PUFA-diet

Description: Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: polyunsaturated fatty acid diet (PUFA) will have P/S ratio 1.0.

Type: Other

P/S-ratio 1.0

Name: SAFA-diet

Description: Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: Saturated fatty acid diet (SAFA) will polyunsaturated/saturated (P/S) ratio of 0.3.

Type: Other

P/S-ration 0.3


Primary Outcomes

Description: insulin sensitivity measured by oral glucose tolerance test at the beginning of the first, randomised diet

Measure: insulin sensitivity

Time: week 0

Description: insulin sensitivty measured by oral glucose tolerance test after the first diet

Measure: insulin sensitivity

Time: week 8

Description: Insulin sensitivity measured by oral glucose tolerance test in the beginning of the second, randomised diet

Measure: insulin sensitivity

Time: week 10

Description: insulin sensitivity measured by oral glucose tolerance test after the second diet

Measure: insulin sensitivity

Time: week 18

Secondary Outcomes

Measure: peripheral blood mononuclear cell gene expression

Time: week 8

Measure: peripheral blood mononuclear cell gene expression

Time: week 18

Description: serum lipids, including serum lipidomics and fatty acid composition

Measure: serum lipids

Time: week 8

Description: serum lipids, including serum lipidomics and fatty acid composition

Measure: serum lipids

Time: week 18

Description: inflammation measured as serum cytokines and adipose tissue inflammation

Measure: inflammation

Time: week 8

Description: inflammation measured as serum cytokines and adipose tissue inflammation

Measure: inflammation

Time: week 18

Description: energy expenditure and the rates of substrate oxidation

Measure: energy expenditure

Time: week 8

Description: energy expenditure and the rates of substrate oxidation

Measure: energy expenditure

Time: week 18

Measure: insulin secretion

Time: week 8

Measure: insulin secretion

Time: week 18

Measure: adipose tissue gene expression

Time: week 8

Measure: adipose tissue gene expression

Time: week 18

Purpose: Prevention

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 P12A

The role of the Pro12Ala polymorphism in diabetes risk has also been verified in meta-analysis. --- Pro12Ala ---

Inclusion Criteria: - BMI >20kg/m2 <29kg/m2 - Pro12Pro and Ala12Ala genotypes of PPARG Pro12Ala polymorphism - participation to METSIM-study (METabolic Syndrome in Men, currently >10000 men included from the population living in Kuopio, principal investigator Markku Laakso) - normoglycemia Exclusion Criteria: - type 2 diabetes - other chronic diseases Inclusion Criteria: - BMI >20kg/m2 <29kg/m2 - Pro12Pro and Ala12Ala genotypes of PPARG Pro12Ala polymorphism - participation to METSIM-study (METabolic Syndrome in Men, currently >10000 men included from the population living in Kuopio, principal investigator Markku Laakso) - normoglycemia Exclusion Criteria: - type 2 diabetes - other chronic diseases Insulin Sensitivity Insulin Resistance Hypersensitivity Obesity and type 2 diabetes are increasing in all western countries, including Finland. --- Pro12Ala ---

Inclusion Criteria: - BMI >20kg/m2 <29kg/m2 - Pro12Pro and Ala12Ala genotypes of PPARG Pro12Ala polymorphism - participation to METSIM-study (METabolic Syndrome in Men, currently >10000 men included from the population living in Kuopio, principal investigator Markku Laakso) - normoglycemia Exclusion Criteria: - type 2 diabetes - other chronic diseases Inclusion Criteria: - BMI >20kg/m2 <29kg/m2 - Pro12Pro and Ala12Ala genotypes of PPARG Pro12Ala polymorphism - participation to METSIM-study (METabolic Syndrome in Men, currently >10000 men included from the population living in Kuopio, principal investigator Markku Laakso) - normoglycemia Exclusion Criteria: - type 2 diabetes - other chronic diseases Insulin Sensitivity Insulin Resistance Hypersensitivity Obesity and type 2 diabetes are increasing in all western countries, including Finland. --- Pro12Ala --- --- Pro12Ala ---

The role of the Pro12Ala polymorphism in diabetes risk has also been verified in meta-analysis. --- Pro12Ala ---

Based on these findings the investigators created in collaboration with Johan Auwerx an Pro12Ala animal model that demonstrated a differential effect of dietary fat composition depending on the genotype. --- Pro12Ala ---

However, an important conclusive proof that subjects selected based on their Pro12Ala genotype would respond differently to specifically tailored diet modification is still needed. --- Pro12Ala ---



HPO Nodes


HPO:
Allergy
Genes 21
CHD1 TGM5 ADA PLA2G7 MTOR FOXP3 PGM3 CARMIL2 SIK3 CCDC28B BBS1 NRXN1 IL4R COX4I2 MS4A2 PLCG2 SPINK5 CSTA CNTNAP2 RBM8A PGM3
Insulin resistance
Genes 122
LIPC KCNJ11 HNF1A GCGR STAT3 BSCL2 HSD3B2 ABCC8 AGPAT2 INS LMNA LMNB2 LMNA PDX1 ABCC8 ABCC8 INS CAV1 FOS ZMPSTE24 LMNA HYMAI LIPE BSCL2 CIDEC PLIN1 PPARG HYMAI CAV1 XRCC4 ADCY3 SLC2A2 CEP19 IGFALS LMNA MAPK8IP1 TCF7L2 DBH NEUROD1 NSMCE2 AKT2 PPARG XRCC4 IGF1 GATA6 NEUROD1 GCK AKT2 POLD1 PAX4 BSCL2 ALMS1 LMNA PDX1 PMM2 KCNJ11 HNF1A PTF1A HYMAI PLAGL1 HNF1B KLF11 NSMCE2 PIK3R1 BLK LIPE KCNJ11 GPD2 HMGA1 CEL INSR INSR ZFP57 CAV1 LEP ABCC8 SLC12A3 SLC30A8 EIF2AK3 LMNA GCK PDX1 RETN PDX1 CAVIN1 HNF4A IRS1 PIK3R1 ZFP57 PLAGL1 LEPR KCNJ11 ZMPSTE24 GCK MFN2 WFS1 ALMS1 APPL1 DCAF17 ABCC8 PAX4 ZMPSTE24 HSD11B1 AGPAT2 ENPP1 IRS2 HNF4A WRN PTPN1 PPP1R3A LMNA PAX4 PPARG IGF2BP2 KCNJ11 LMNA MTNR1B CLCNKB PPARG CAVIN1 EIF2AK3 CYP19A1