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NCT03620773 · ClinicalTrials.gov registry record · Phase 1
Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes
A Phase 1 study of Obesity and Diabetes Mellitus, Type 2, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03620773: Completed Phase 1 study of Obesity and Diabetes Mellitus, Type 2, sponsored by University of Colorado, Denver.
NCT03620773 is a Phase 1 study of Obesity and Diabetes Mellitus, Type 2 that has completed, run by University of Colorado, Denver. The registered enrollment target is 24 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03620773, a Phase 1 study of Obesity and Diabetes Mellitus, Type 2, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Type 2 diabetes (T2D) in youth is increasing in prevalence in parallel with the obesity epidemic. In the US, almost half of patients with renal failure have DKD, and ≥80% have T2D. Compared to adult-onset T2D, youth with T2D have a more aggressive phenotype with greater insulin resistance (IR), more rapid β-cell decline and higher prevalence of diabetic kidney disease (DKD), arguing for separate and dedicated studies in youth-onset T2D. Early DKD is characterized by changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure with resultant hyperfiltration, is common in Y-T2D, and predicts progressive DKD. Studies evaluating the two currently approved medications for treating T2D in youth (metformin and insulin) have shown these medications are not able to improve β-cell function over time in the youth. However, recent evidence suggests that bariatric surgery in adults is associated with improvements in diabetes outcomes, and even T2D remission in many patients. Limited data in youth also supports the benefits of bariatric surgery, regarding weight loss, glycemic control in T2D, and cardio-renal health. While weight loss is important, the acute effect of bariatric surgery on factors such as insulin resistance likely includes weight loss-independent mechanisms. A better understanding of the effects of bariatric surgery on pancreatic function, intrarenal hemodynamics, renal O2 and cardiovascular function in youth with obesity with or without diabetes is critical to help define mechanisms of surgical benefits, to help identify potential novel future non-surgical approaches to prevent pancreatic failure, DKD and cardiovascular disease. The investigators' overarching hypotheses are that: 1) Y-T2D is associated with IR, pancreatic dysfunction, intrarenal hemodynamic dysfunction, elevated renal O2 consumption and cardiovascular dysfunction which improve with bariatric surgery, 2) The early effect of bariatric surgery on i
Primary Outcome
Measured by Mixed Meal Tolerance Test (MMTT)
Conditions Studied
Interventions
- DRUG Aminohippurate Sodium Inj 20%
- PROCEDURE Vertical Sleeve Gastrectomy
- PROCEDURE Renal Biopsy
- DRUG Iohexol Inj 300 mg/mL
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2024-09-25 |
| Phase | Phase 1 |
What the finished NCT03620773 record still lists
NCT03620773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower).
The record links to 10 conditions, with Obesity appearing as the primary indexed condition, and to 4 interventions - of which Aminohippurate Sodium Inj 20% is the first listed.
NCT03620773 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT03620773 about?
NCT03620773 is a clinical study titled "Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes". Type 2 diabetes (T2D) in youth is increasing in prevalence in parallel with the obesity epidemic. In the US, almost half of patients with renal failure have DKD, and ≥80% have T2D. Compared to adult-onset T2D, youth with T2D have a more aggressive phenotype with greater insulin resistance (IR), more...
What is the current status of trial NCT03620773?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-10-01. Estimated completion is 2024-09-25.
What conditions does trial NCT03620773 study?
This clinical trial studies the following conditions: Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 2 Diabetes Mellitus, Weight Loss.
What interventions are being tested in trial NCT03620773?
The interventions under investigation include: Aminohippurate Sodium Inj 20% (DRUG), Vertical Sleeve Gastrectomy (PROCEDURE), Renal Biopsy (PROCEDURE), Iohexol Inj 300 mg/mL (DRUG).
Who is sponsoring clinical trial NCT03620773?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03620773 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03620773's enrollment target sits among peer trials
24 909th of 1053 higher than 127 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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