Health TrialsbyHealthPanel

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

ConditionsType 2 Diabetes MellitusDiabetic Kidney DiseaseAdolescent ObesityPre DiabetesKidney HypoxiaPuberty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-14
SponsorPetter Bjornstad

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

HbA1c ≥6.0% for untreated high-risk group

BMI ≥ 85th %ile for high-risk group

Normal HbA1c ≤5.6% for control group

Type 1 diabetes (T1D) Antibody negative

Disqualifiers

History of Chronic kidney disease (CKD) or acute kidney injury (AKI)

Metabolic disorder prohibiting safe fasting

Iodine or penicillin allergy

Pregnancy

Trial population

The investigators propose to address the specific aims of this study in an accelerated longitudinal project with 40 adolescents with normal HbA1c (≤5.6%) and 60 with overweight/obesity and/or newly diagnosed T2D (BMI≥85%ile) and elevated HbA1c (≥6.0%) or on anti-diabetic medications ranging from TS 1-4 (Ages 8-14 yr). They will be studied annually for 2 years.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Youth with overweight/obesity and/or newly diagnosed T2D and elevated HbA1c3 interventions
Group B: Healthy normal-weight controls3 interventions

Trial outcomes

Primary outcomes

1

Effective renal plasma flow (ERPF)

Measured by PAH Clearance

Time frame
3 Hours
2

Glomerular Filtration Rate (GFR)

Measured by iohexol clearance

Time frame
3 hours

Secondary outcomes

1

Insulin Sensitivity

Measured by IV glucose tolerance test (IVGTT)

Time frame
3 hours
2

Renal perfusion

Arterial spin labeling (ASL) MRI

Time frame
10 min
3

Renal oxygenation

Blood oxygen level dependent (BOLD) MRI

Time frame
60 min

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Petter Bjornstad

Lead sponsor

Seattle Children's Hospital

Sponsor institution

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Seattle Children's Hospital

Collaborator

University of Colorado, Denver

Collaborator

Source ClinicalTrials.gov
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