SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00593476

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Pilot Study to Assess the Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control

The purpose of this trial is to study the safety and efficacy of a pre-packaged, portion controlled meal plan on weight loss and glycemic control in overweight and obese patients with type 2 diabetes. Aim 1 - Effects on Weight Assess the effects of a pre-packaged, portion controlled meal plan on weight loss in overweight and obese patients with type 2 diabetes. The researchers hypothesize that the pre-packaged, portion controlled diet (PCD) will produce a greater weight loss than a diabetes support and education (DSE) program at 12 weeks. The study will be powered to detect between group differences of 3% of body weight. Secondarily, the researchers will assess whether there are any differences in weight during the secondary phase from weeks 13-24 when both groups will consume a PCD diet. Aim 2 - Effects on Glycemic Control Assess the effects of a pre-packaged, portion controlled meal plan on glycemic control in overweight and obese patients with type 2 diabetes. The researchers hypothesize that the PCD will show greater improvement in HbA1c levels than a DSE group at 12 weeks. The study will be powered to detect between group differences of .5% in HbA1c. Secondarily, improvements and differences in HbA1c from weeks 13-24 when both groups are consuming a PCD will be assessed.

NCT00593476 Type 2 Diabetes
MeSH: Diabetes Mellitus, Type 2
HPO: Type II diabetes mellitus

2 Interventions

Name: PCD

Description: pre-packaged, portion-controlled (PCD) meal plan for 24 weeks

Type: Other

PCD

Name: DSE

Description: 12 weeks of diabetes support and education (DSE) (weeks 0-12) and then crosses over to 12 weeks of PCD from weeks 13-24

Type: Other

DSE


Primary Outcomes

Measure: Changes in weight at 12 weeks.

Time: 12 weeks

Secondary Outcomes

Measure: Changes in HbA1c, lipids, inflammatory markers (hs-CRP), fasting glucose, blood pressure, waist circumference and survey measures at 12 weeks.

Time: 12 weeks

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 K121Q

We will use these samples to determine the possibility that the common genetic variant ENPP1 K121Q could predispose diabetic and metabolic syndrome subjects to respond better to weight loss intervention than those who have the common variant K121K. --- K121Q ---



HPO Nodes


HPO:
Type II diabetes mellitus
Genes 152
MKRN3 SNORD115-1 SPATA7 CERKL PRPF31 LRAT KLF11 IFT140 HNF1A BEST1 HNF1B ARL2BP NR2E3 GLRX5 MAK AHI1 MAGEL2 ABCA4 PDE6A PDE6G IMPDH1 OFD1 STUB1 SPINK1 NRL CLIP2 PDE6B IFT172 AMACR KIZ CDHR1 CYP19A1 DHX38 INSR RBP3 WRN MC4R HGSNAT PDX1 IPW KIAA1549 PWRN1 BBS2 BAZ1B PEX10 RDH12 POMGNT1 PRPH2 DHDDS ARHGEF18 PCARE NDN PRPF6 GCK IDH3B AGBL5 RFC2 XRCC4 GTF2IRD1 PRPF8 RGR TUB SLC7A14 AR SNORD116-1 TULP1 POLR3A RHO CRB1 MKRN3-AS1 CRX BLM RLBP1 PPP1R3A ARL6 TTC8 PROM1 LIG4 NEK2 LIMK1 EYS ARL3 SAG FBN1 GTF2I PNPLA6 SLC12A3 LMNA COX1 ALMS1 BRAF COX2 COX3 GUCA1B CLCNKB IFT88 KLHL7 PRPF4 PRPF3 REEP6 FAM161A ABCC8 ZNF408 ND1 ND4 ND5 ND6 NPAP1 SCAPER FSCN2 AHR PRCD TRNE TRNF ROM1 AKT2 TRNH RP9 PLCD1 RP1 ELN TRNK PAX4 RP2 TRNL1 RPGR ATM PWAR1 SEMA4A CTNNB1 C8ORF37 HERC2 TRNQ MERTK TRNS1 TRNS2 TOPORS TRNW USH2A RPE65 CLRN1 CNGB1 CNGA1 SNRNP200 SNRPN TBL2 MOG CEP19 CA4 IMPG2 PCNT ZNF513