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dbGaP phs000408 eMERGE Genome-Wide Association Studies of Obesity - Eligibility

- 12-10-22 - 5 Formulieren, 1 Itemgroep, 11 Data-elementen, 1 Taal
Itemgroep: IG.elig
Principal Investigator: Glenn S. Gerhard, MD, Weis Center for Research, Geisinger Clinic, Danville, PA, USA MeSH: Type 2 Diabetes,Obesity,Bariatric Surgery https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000408 The Geisinger eMERGE Genome-Wide Association Studies of Obesity Project is a genetic study of a cohort of primarily Caucasian patients with extreme obesity who have undergone bariatric surgery. Roux-en-Y gastric bypass (RYGB) surgery, in which intestinal anatomy is altered, dramatically ameliorates and/or eliminates Type 2 diabetes mellitus (T2D) in 50-80% of patients within hours to days following surgery, well before significant weight loss, in contrast to other types of bariatric surgeries, such as gastric banding, that attenuate insulin resistance as a result of substantial weight loss that occurs over months to years. The molecular mechanism by which RYGB exerts this clinical phenomenon occurs is not known. The goal of this project was to conduct a genome-wide association study (GWAS) to identify genetic variants associated with amelioration in T2D defined by medication independence. Identifying genetic variants that influence the dramatic resolution of T2D from RYGB may identify novel targets for pharmacological T2D therapies and/or identify patients in whom RYGB may not be effective.

pht002438.v1.p1

1 Itemgroep 5 Data-elementen

pht002439.v1.p1

1 Itemgroep 4 Data-elementen

pht002440.v1.p1

1 Itemgroep 24 Data-elementen

pht002441.v1.p1

1 Itemgroep 4 Data-elementen

dbGaP phs000380 eMERGE Genome-Wide Association Studies of Obesity (Metabochip) - Eligibility

- 12-10-22 - 5 Formulieren, 1 Itemgroep, 11 Data-elementen, 1 Taal
Itemgroep: IG.elig
Principal Investigator: Glenn S. Gerhard, MD, Weis Center for Research, Geisinger Clinic, Danville, PA, USA MeSH: Type 2 Diabetes,Obesity,Bariatric Surgery https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000380 The Geisinger eMERGE Genome Wide Association Studies of Obesity (Metabochip) Project is a genetic study of a cohort of primarily Caucasian patients with extreme obesity who have undergone bariatric surgery. Roux-en-Y gastric bypass (RYGB) surgery, in which intestinal anatomy is altered, dramatically ameliorates and/or eliminates Type 2 diabetes mellitus (T2D) in 50-80% of patients within hours to days following surgery, well before significant weight loss, in contrast to other types of bariatric surgeries, such as gastric banding, that attenuate insulin resistance as a result of substantial weight loss that occurs over months to years. The molecular mechanism by which RYGB exerts this clinical phenomenon is not known. The goal of this project was to conduct a genome wide association study (GWAS) to identify genetic variants associated with amelioration in T2D defined by medication independence. Identifying genetic variants that influence the dramatic resolution of T2D from RYGB may identify novel targets for pharmacological T2D therapies and/or identify patients in whom RYGB may not be effective.

pht002456.v1.p1

1 Itemgroep 4 Data-elementen

pht002457.v1.p1

1 Itemgroep 4 Data-elementen

pht002458.v1.p1

1 Itemgroep 25 Data-elementen

pht002459.v1.p1

1 Itemgroep 3 Data-elementen

Eligibility Type 2 Diabetes NCT02301806

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM; ODM derived from: https://clinicaltrials.gov/show/NCT02301806

Visit 7 / Early Termination Diab-MedSat [QS_3] NCT01117584

- 20-09-21 - 1 Formulier, 9 Itemgroepen, 24 Data-elementen, 1 Taal
Itemgroepen: General Information, 1. Over the past two weeks, how bothered have you been by..., 2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?, 3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to...., 4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with...., 5. Thinking about your diabetes medication(s) over the past two weeks...., 6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to..., 7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ...., 8. Overall, based on your current experiences with your diabetes medications...
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Visit 9 Follow-up Diab-MedSat [QS_3] NCT01117584

- 20-09-21 - 1 Formulier, 9 Itemgroepen, 24 Data-elementen, 1 Taal
Itemgroepen: General Information, 1. Over the past two weeks, how bothered have you been by..., 2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?, 3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to...., 4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with...., 5. Thinking about your diabetes medication(s) over the past two weeks...., 6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to..., 7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ...., 8. Overall, based on your current experiences with your diabetes medications...
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Visit 2 Baseline Diab-MedSat [QS_3] NCT01117584

- 20-09-21 - 1 Formulier, 9 Itemgroepen, 24 Data-elementen, 1 Taal
Itemgroepen: General Information, 1. Over the past two weeks, how bothered have you been by..., 2. Over the past two weeks, how bothered have you been by any of the following due to your diabetes medication(s)?, 3. Over the past past two weeks, how dissatisfied or satisfied have you been with the ability of your diabetes medication(s) to...., 4. Overall, over the past two weeks, how dissatisfied or satisfied have you been with...., 5. Thinking about your diabetes medication(s) over the past two weeks...., 6. Over the past two weeks, how often has taking your diabetes medication(s) as prescribed interfered with your ability to..., 7. Overall, thinking about each of the aspects of your diabetes medication(s) as mentioned above, how dissatisfied or satisfied have you been with ...., 8. Overall, based on your current experiences with your diabetes medications...
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Eligibility Type 2 Diabetes Weight Loss NCT01601574

- 23-06-21 - 1 Formulier, 2 Itemgroepen, 39 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Weight Loss Study for People With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01601574

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Meal B/L/D V12 8

- 11-08-20 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Breakfast, Lunch, Dinner
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Meal B/L/D V6 21-DF

- 11-08-20 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Breakfast, Lunch, Dinner
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Meal B/L/D V10 2-DF

- 11-08-20 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Breakfast, Lunch, Dinner
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Meal B/L/D V9 10

- 11-08-20 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Breakfast, Lunch, Dinner
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin - Meal B/L/D V4 17-DF

- 11-08-20 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Breakfast, Lunch, Dinner
The primary focus of this first time in human (FTIH) study was to evaluate the safety and tolerability of GSK1292263 and to estimate GSK1292263 pharmacokinetic (PK) parameters and pharmacodynamic (PD) effects in healthy volunteers. Subject: FTIH, oral, safety, tolerability, pharmacokinetics, glucose, pharmacodynamics, male, female, gastric emptying Indication Studied: Type 2 Diabetes Mellitis Study ID: 111596 Clinical Study ID: 111596 Study Title: A study in healthy volunteers of single doses of orally administered GSK1292263 to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound alone and when co-administered with sitagliptin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00783549 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1292263, Sitagliptin Trade Name: N/A Study Indication: Dyslipidaemias

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