SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03627104

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity

The prevention of obesity and its main medical complications, such as hypertension, type 2 diabetes and cardiovascular diseases, have been become a health priority. One of the most frequent metabolic complications in obesity is the insulin resistance and is the most important risk factor for the development of coronary diseases. The weight loss induced by the restriction of dietary energy is the cornerstone of therapy for people with obesity, as it improves or even regularizes insulin sensitivity and related comorbidities. However, weight loss induced by diet also decreases lean tissue mass, which could result in adverse effects on physical function. Although, regularly recommended to increase protein intake during weight loss, there is evidence to suggest that high protein intake could have deleterious metabolic effects. On the other hand, there is an association between the type of protein consumption, mainly the concentration of branched-chain amino acids (BCAAs) and insulin resistance during the dietary energy restriction in the therapy of obesity. There are multiple factors that influence the concentration of BCAAs and insulin resistance, which can be by phenotypic or genetic modification. The phenotypic modification refers to race, sex and dietary pattern. Meanwhile, the genetic modification refers to the activity of the enzymes responsible for the catabolism of BCAAs and genetic variants, such as the polymorphisms of a single nucleotide of said enzymes. A randomized controlled trial will be conducted with 160 participants (80 women and 80 men) divided by a draw in 4 groups, each for 20 participants. A feeding plan will be assigned according to the distribution of proteins (standard or high) and type of protein (animal or vegetable). The main aim of this study is to evaluate the effect on the amount and type of dietary protein and energy restriction on insulin resistance in subjects with obesity in a period of 1 month, considering the main factors that influence the concentration of BCAAs. In this way, evidence will be provided on what type of dietary intervention is most convenient for weight loss in subjects with insulin resistance and obesity.

NCT03627104 Obesity Insulin Resistance
MeSH: Obesity Insulin Resistance
HPO: Insulin resistance Obesity

4 Interventions

Name: Normoprotein diet with animal protein

Description: Each patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with percentage of standard protein (12-18%) with a predominance of animal protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).

Type: Dietary Supplement

Normoprotein diet with animal protein

Name: Normoprotein diet with vegetable protein

Description: Each patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with percentage of standard protein (12-18%) with a predominance of vegetable protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).

Type: Dietary Supplement

Normoprotein diet with vegetable protein

Name: High-protein diet with animal protein

Description: Each patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with high-protein percentage (25-35%) with a predominance of animal protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).

Type: Dietary Supplement

High-protein diet with animal protein

Name: High-protein diet with vegetable protein

Description: ach patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with high-protein percentage (25-35%) with a predominance of vegetable protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).

Type: Dietary Supplement

High-protein diet with vegetable protein


Primary Outcomes

Description: Change in the index HOMA-IR. The HOMA IR index will be calculated by the following equation: glucose (mg / dl) x insulin (mUI / ml) / 405 before and after of dietary intervention

Measure: Resistance insulin

Time: Baseline to 1-month

Secondary Outcomes

Description: Change in the concentration of the amino acid profile, mainly of branched chain amino acids

Measure: Amino acid profile

Time: Baseline to 1-month

Description: Change in fat mass, lean mass and skeletal muscle mass percentage

Measure: Change in body composition

Time: Baseline to 1-month

Description: change in body weight before and after of dietary intervention

Measure: Change in body weight

Time: Baseline to 1-month

Description: Change in waist circumference before and after of dietary intervention

Measure: Change in waist circumference

Time: Baseline to 1-month

Description: Change in grip strength before and after the intervention by dynamometry

Measure: Change in grip strength

Time: Baseline to 1-month

Description: The respiratory coefficient will be determined by indirect calorimetry

Measure: Change in respiratory quotient

Time: Baseline to 1-month

Description: The concentration of serum glucose will be determined by autoanalyzer before and after the intervention

Measure: Change in glucose serum

Time: Baseline to 1-month

Description: The concentration of serum total cholesterol will be determined by autoanalyzer before and after the intervention

Measure: Change in total cholesterol serum

Time: Baseline to 1-month

Description: The concentration of serum HDL-cholesterol will be determined by autoanalyzer before and after the intervention

Measure: Change in HDL cholesterol serum

Time: Baseline to 1-month

Description: The concentration of serum triglycerides will be determined by autoanalyzer before and after the intervention

Measure: Change in triglycerides serum

Time: Baseline to 1-month

Description: The concentration of serum LDL cholesterol will be determined by autoanalyzer before and after the intervention

Measure: Change in LDL cholesterol serum

Time: Baseline to 1-month

Description: The concentration of free fatty acids will be determined before and after the intervention

Measure: Change in free fatty acids serum

Time: Baseline to 1-month

Description: The concentration of serum liver enzymes will be determined by autoanalyzer before and after the intervention

Measure: Change liver function tests

Time: Baseline to 1-month

Description: The concentration of serum leptin will be determined by ELISA kit before and after the intervention

Measure: Change in concentration of leptin serum

Time: Baseline to 1-month

Description: The concentration of serum adiponectin will be determined by ELISA kit before and after the intervention

Measure: Change in concentration of adiponectin serum

Time: Baseline to 1-month

Description: The concentration of serum C- reactive protein will be determined by autoanalyzer before and after the intervention

Measure: Change in the concentration of C-reactive protein

Time: Baseline to 1-month

Description: the blod pressure will be determined before and after the intervention

Measure: Change in systolic and diastolic blood pressure

Time: Baseline to 1-month

Description: HOMA (IR-HOMA) which is calculated glucose (mg / dl) x insulin (mUI / ml) / 405 before and after of dietary intervention

Measure: Change of the HOMA index according to the presence or absence of polymorphism related to the metabolism of branched chain amino acids (rs11548193 and rs45500792).

Time: Baseline to 1- month

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 rs11548193

Change of the HOMA index according to the presence or absence of polymorphism related to the metabolism of branched chain amino acids (rs11548193 and rs45500792).. HOMA (IR-HOMA) which is calculated glucose (mg / dl) x insulin (mUI / ml) / 405 before and after of dietary intervention.


2 rs45500792

Change of the HOMA index according to the presence or absence of polymorphism related to the metabolism of branched chain amino acids (rs11548193 and rs45500792).. HOMA (IR-HOMA) which is calculated glucose (mg / dl) x insulin (mUI / ml) / 405 before and after of dietary intervention.



HPO Nodes


HPO:
Insulin resistance
Genes 56
BLK PPP1R3A KLF11 HNF1A HNF1B IGF1 LIPE NEUROD1 IGFALS ZMPSTE24 SLC12A3 CEL LMNA ALMS1 CLCNKB PTF1A INS PIK3R1 POLD1 FOS ABCC8 CYP19A1 CIDEC KCNJ11 AGPAT2 INSR ZFP57 WRN DCAF17 GATA6 PDX1 MFN2 APPL1 PLAGL1 AKT2 CAVIN1 BSCL2 HSD3B2 DBH GCK LMNB2 PAX4 CAV1 HSD11B1 PPARG XRCC4 NSMCE2 PLIN1 HNF4A HYMAI EIF2AK3 LEP LEPR STAT3 CEP19 PMM2
Obesity
Genes 318
MYT1L SOX2 MKRN3 PCSK1 SOX3 MKKS RAB23 GABRD SNORD115-1 SPATA7 SOX10 CERKL PRPF31 LRAT IFT140 ARL2BP PNKP MAK CNNM2 AHI1 ABCA4 PDE4D ZBTB20 PDE6A PDE6G IMPDH1 HDAC4 CEL ATRX TRAF3IP1 PDE6B PDSS1 CYP7A1 INS HLA-DQB1 IFT172 KIZ CDHR1 SMC1A HLA-DRB1 CYP19A1 RPS6KA3 SDCCAG8 IQSEC2 DHX38 APC2 HDAC8 MC4R GATA4 PDX1 IPW BBS1 PWRN1 BBS2 CDH23 BBS4 DHDDS SRY NDN PRPF6 GCK PSMD12 WNT4 AGBL5 DCC RREB1 PTEN HNF4A SLC10A7 TRIP12 BBS9 TUB MECP2 BDNF SNORD116-1 HESX1 FGF17 MKS1 TULP1 HIRA TNFSF4 BLK GHR SEMA3A XYLT1 ARL6 TTC8 PROM1 BPTF NEK2 ZDHHC15 ANOS1 SAG NEUROD1 KIDINS220 KISS1R PNPLA6 ALMS1 BRAF PROKR2 CANT1 KLHL7 REEP6 UBE3A FAM161A ABCC8 HS6ST1 RBMX KCNJ11 MCM3AP SYNE2 UFD1 HACE1 ARNT2 ARL13B NPAP1 SCAPER FSCN2 AHR PRCD KMT2A FGF8 AKT2 FGFR1 FGFR3 TACR3 FLRT3 GNAS HSD11B1 PWAR1 SEMA4A HERC2 MERTK FTO PRMT7 FHL1 USH2A CLRN1 CNGB1 CNGA1 KDM6A NIPBL NR0B2 PHIP TRAPPC9 TBX1 MOG CA4 IMPG2 PDE11A GP1BB RAD21 CUL4B PROK2 NPHP1 FLII CACNA1S IFT27 GNAS-AS1 KLF11 DPYD TBX3 HNF1A BEST1 NR2E3 RAP1A RAP1B MAGEL2 DEAF1 FMR1 COMT OFD1 WDR34 SLC25A4 NRL CLIP2 IFT74 RNPC3 INPP5E SYNE1 NTRK2 DUSP6 LZTFL1 CEP290 RBP3 HGSNAT KCNAB2 WT1 BBIP1 POMC NSD1 KIAA1549 PHF6 BAZ1B RDH12 POMGNT1 PRPH2 SHOX ARHGEF18 PCARE POU3F4 SPG11 CHD7 TMEM43 SIN3A AIP BBS5 H6PD HUWE1 APOE IDH3B PPARG SIM1 RFC2 XRCC4 SLC7A7 GTF2IRD1 SKI PRPF8 ADNP THOC2 CCDC141 CREBBP RGR ZNF365 SLC7A14 JMJD1C SHANK3 LEP WDPCP LEPR CEP164 SH2B1 RHO CRB1 KIF7 BBS10 MKRN3-AS1 MTFMT CRX ZNF711 RLBP1 USP8 MLXIPL LIMK1 SETD2 EYS ARL3 KMT2D IGF1 LIPE OTX2 IGF1R GTF2I IGFALS NSMF EGF SEC24C LMNA MEGF8 GUCA1B IFT88 ARVCF WDR11 SMC3 PRPF4 FEZF1 P2RY11 PRPF3 SETD5 TRIM32 BBS7 ATP6AP2 EIF2S3 ZNF408 ARMC5 SPRY4 DYRK1B EHMT1 PRKAR1A APPL1 FOXP1 ROM1 RP9 RP1 ELN PAX4 RP2 RPGR PAX6 RERE EMD CTNNB1 C8ORF37 KCNJ18 LAS1L TOPORS STX16 IL17RD ERMARD CTSH PRDM16 BBS12 RPE65 SNRNP200 SNRPN TBL2 EP300 VPS13B HCRT AFF4 MAN1B1 RAI1 CEP19 SMAD4 GABRA3 PCNT ZNF513