Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Petter Bjornstad
Study ID
NCT05008276
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 14 Years
Healthy Volunteers
Accepted

Interventions

  • Aminohippurate Sodium Inj 20% — DRUG
    Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
  • Iohexol Inj 300 MG/ML — DRUG
    Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
  • Dextran 40 — DRUG
    Diagnostic aid/agent used to measure glomerular size and selectivity

Study Details

Early diabetic kidney disease (DKD) occurs in 50-70% of youth with type 2 diabetes (T2D) and confers high lifetime risk of dialysis and premature death. Youth-onset T2D typically manifests during or shortly after puberty in adolescents with obesity. Epidemiological data implicate puberty as an accelerator of kidney disease in youth with obesity and diabetes and the investigators posit that the link between puberty and T2D-onset may explain the high burden of DKD in youth-onset T2D. A better understanding of the impact of puberty on kidney health is needed to promote preservation of native kidney function, especially in youth with T2D.

Key Dates

Start date
Sep 27, 2021
Status verified
Mar 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Youth with overweight/obesity and/or newly diagnosed T2D and elevated HbA1c
    All participants will undergo GFR (Iohexol Inj 300 MG/ML), EPRF (Aminohippurate Sodium Inj 20%), Dextran sieving (Dextran 40 Sodium Inj 0.9%), IVGTT for insulin sensitivity, in addition to BOLD and ASL Kidney MRI
  • Arm: Healthy normal-weight controls
    All participants will undergo GFR (Iohexol Inj 300 MG/ML), EPRF (Aminohippurate Sodium Inj 20%), Dextran sieving (Dextran 40 Sodium Inj 0.9%), IVGTT for insulin sensitivity, in addition to BOLD and ASL Kidney MRI

Primary Outcome Measure

Effective renal plasma flow (ERPF) [ Time Frame: 3 Hours ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Megan Kelsey, MD, MS
[email protected]
720-777-0991
Megan Kelsey, MD, MS (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98102
Petter M Bjornstad, MD
[email protected]
(206) 616 3543
Petter M Bjornstad, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Children's Hospital Colorado· Aurora, COSeattle Children's Hospital· Seattle, WA

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