Research Studies

Division of Endocrinology and Diabetes Research Studies

Find research studies available to children cared for by the Division of Endocrinology and Diabetes team.
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Clinical trial
Children (18)
Adults (15)
Healthy Controls (6)
MRI/Imaging Studies (4)
One-Time Visit Studies (3)
Remote (Online / Phone Call Only) Studies (1)

Clinical Trial Phases
Pilot (1)
Phase I (3)
Phase II (5)
Phase III (5)
Phase IV (2)
N/A (9)

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Recruiting (14)
Non-recruiting (8)

Related Specialties and Programs
Division of Endocrinology and Diabetes (22)
Department of Pediatrics (3)
Diabetes Center (3)
Cystic Fibrosis Center (1)
Healthy Weight Program (1)

Specialty
Diabetes Care (3)
Endocrinology (22)
Gastroenterology (1)
General Pediatrics (3)
Pulmonology (1)

Beta-cell Responsiveness to the Incretin Hormones (Aim1)
The goal of the study extension is to see whether the incretin hormone GIP increases insulin secretion in individuals with CF and normal glucose tolerance compared to individuals without CF and normal glucose tolerance. This study includes 3 or 4 visits.

Phase: N/A

Actively recruiting: Yes

Category: Adults, Healthy Controls

Blood Sugar Stability in Individuals with Hyperinsulinism
The purpose of the study is to evaluate blood sugar levels and beta-cell function in adolescents and adult with KATP hyperinsulinism whom did not undergo pancreatectomy. We will perform oral glucose tolerance tests, glucose potentiated arginine tests, and evaluate blood sugars in home environment by using continuous glucose monitoring for 10 days.

Phase: Pilot

Actively recruiting: No

Category: Adults, Children

CAHptain Study
 The primary purpose of the CAHptain study is to explore the safety and efficacy of tildacerfont in children and adolescents aged 2 to 17 years of age with classic CAH, and evaluate if it may improve hormonal balance and allow children to take lower doses of glucocorticoids.

Phase: Phase II

Actively recruiting: Yes

Category: Children

Canagliflozin in Children with Type 2 Diabetes
The goal of this study is to investigate the efficacy and safety of Canagliflozin (which is experimental) in children and adolescents ages 10 to 18 years old with Type 2 diabetes and poor control (i.e., an HbA1c of 6.5% to 10.5%). Study drug or placebo would be taken alone or with metformin or insulin as needed. Monitoring tests include blood, urine, physical exams, vital signs, blood sugar and ketone monitoring, diabetes management counseling.

Phase: Phase III

Actively recruiting: No

Category: Children

CFRD-Pilot Study
The purpose of this research study is to examine and understand the various mechanisms that contribute to CFRD and gain a better understanding of potential means to treat CFRD. Participation will include 2-3 visits, home monitoring, and will last about 2 years.

Phase: N/A

Actively recruiting: Yes

Category: Adults, Children, Healthy Controls

Childhood Type 2 Diabetes Study of a Single Dose of "LY3209590" a Weekly Insulin Injection
The aim of this study is to evaluate safety, and tolerability of insulin LY3209590 following a single dose given to children with type 2 diabetes mellitus (T2DM). This will be the first study to evaluate LY3209590 in pediatric patients with T2DM. 
ScreeningAll participants will be screened up to 28 days prior to dosing.
Treatment and Assessment Period On Day 1, participants will receive a single 100-Unit subcutaneous dose of LY3209590 at the clinical research unit. Follow up research visits will be performed on Days 3, 5, 7, 15, 29, 43, and 65. Blood sampling and safety assessments will be performed at each in clinic visit. Before each study visit, subjects will need to fast for at least 8 hours.
A follow-up telephone call will be performed on approximately Day 72. The total time for participation is the study is about 100 days. 

Phase: Phase I

Actively recruiting: Yes

Category: Children

Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism (for children under 1 year of age)
This study is arandomized, double-blind, placebo-controlled study that will evaluate thesafety and efficacy of dasiglucagon in children between the ages of 7 days and12 months who have congenital hyperinsulinism. Dasiglucagon will be given as asubcutaneous infusion while patients are admitted to the hospital. Othertreatments for hyperinsulinism may be changed as allowed while maintaining safeblood sugar levels. For the second part of the study, patients may be able togo home on the medication.

Phase: Phase II, Phase III

Actively recruiting: No

Category: Children

Designate - Siplizumab in T1DM
The goal of this study is to identify a safe dosing regimen for siplizumab in participants with type 1 diabetes. Siplizumab is a drug used to help treat recent onset type 1 diabetes mellitus (T1DM). This study is interested in participants aged 18-45 years with T1DM, who are within 18 months of receiving their diagnosis. Participants will be randomized (selected at random by the study team) to one of four possible treatment groups. All groups will receive weekly siplizumab doses administered subcutaneously (injected into the body through the skin) for a total of 12 weeks.

Phase: Phase I

Actively recruiting: Yes

Category: Adults

DISCOVERY Study

The DISCOVERY Study is a new, national effort to learn about the causes of type 2 diabetes in children. DISCOVERY is for children 9-14 years old who are at higher risk of developing type 2 diabetes. We want to figure out why some children get type 2 diabetes and others do not.

Phase: N/A

Actively recruiting: Yes

Category: Children

HM15136 for the Treatment of Congenital Hyperinsulinism Research Study

Thepurpose of this study is to look at the safety and tolerability (how well youwill react) of the study drug (HM15136) and to determine if it is effective forthe treatment of Congenital Hyperinsulinism (HI). HM15136 is an experimentaldrug which is not approved by the FDA for the treatment of HI. HM15136 is stable and hasa long effect in the body, only requiring it to be given (by injection) once aweek. HM15136 is designed to act likeglucagon, a hormone produced by the pancreas that helps the body maintainnormal blood sugar levels by increasing the glucose produced in the liver andbreaking down glycogen (a form of stored glucose) into the usable glucose form.

Participationlasts for up to 22 weeks and will involve up to 13 study visits. Studyprocedures include taking the study drug for 8 weeks, havingelectrocardiograms, wearing a continuous glucose monitor (CGM) and using ahandheld glucose meter, having blood and urine tests, and completing anelectronic diary.

Themain risks of this study include: nausea, vomiting, diarrhea, abdominal pain,injection site reactions (swelling, itching, bleeding, or pain), loss ofappetite, weight loss, high blood sugar. You may benefit if the study drugproves to be more effective than your current treatment plan in treating lowblood sugar.

Phase: Phase II

Actively recruiting: Yes

Category: Adults, Children