Reducing high insulin levels to improve heart and blood sugar health in type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the cardiometabolic benefits of using an adjunctive therapy to lower iatrogenic hyperinsulinemia in individuals with type 1 diabetes. It also includes participants with Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY) and healthy volunteers to provide a comprehensive understanding of the effects. The intervention involves administering a sodium-glucose cotransporter-2 inhibitor to help reduce insulin requirements and improve heart and blood sugar health. The study aims to assess the impact on insulin response and nitric oxide availability, which are crucial for vascular function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Age: 18-60 years BMI: 18-28 kg/m² Weight: ≥ 50 kg

T1DM Participants:

Duration of T1DM: 1-30 years HbA1c: 5.7-7.5% Insulin Therapy: Using automated insulin delivery

GCK-MODY Participants:

HbA1c: 5.7-7.5% Genetic Confirmation: Positive GCK sequencing

Control Participants:

HbA1c: less than 5.5%

\*\* Exclusion Criteria: Severe Hypoglycemia: ≥1 episode in the past 3 months

Comorbidities:

* Any hospital admissions for diabetic ketoacidosis in the past 6 months
* SBP greater than 140 mmHg and DBP greater than 100 mmHg
* eGFR by MDRD equation of less than 60 mL/min/1.73 m²
* AST or ALT greater than 2.5 times ULN
* Hct less than 35%

Medications:

* Any antioxidant vitamin supplement within 2 weeks before the study
* Any systemic glucocorticoid
* Antipsychotics
* Atenolol, Metoprolol, Propranolol
* Niacin
* Any thiazide diuretic
* Any oral contraceptive pill with greater than 35 mcg ethinyl estradiol
* Growth hormone
* Any immunosuppressant
* Antihypertensive
* Any antihyperlipidemic

Other:

* Pregnancy
* Tanner stage less than 5
* Peri- or post-menopausal women
* Active smoker

T1DM Participants:

Medications: Any diabetes medication except insulin C-peptide: greater than 0.7 ng/mL (fasting)

GCK-MODY Participants:

None specific

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Daniel J Moore, MD, PhD — Vanderbilt University Medical Center
• Study coordinator: Daniel J Moore, MD, PhD
• Email: metabolism@vumc.org
• Phone: 615-322-7427

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system

  This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Toronto and 1 other locations · NCT07831798

• New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery

  This study tests VV-14299 and VV-14300, or VV-14300 alone, in adults with long-standing Type 1 Diabetes whose blood sugar remains poorly controlled despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Melbourne · NCT07829302

• Oral verapamil in newly diagnosed children and teens with type 1 diabetes

  This study tests whether taking verapamil by mouth can help preserve pancreatic beta cells and reduce insulin needs in kids and teens with recently diagnosed type 1 diabetes.

  Recruiting Phase 2/3 Ain Shams University · Cairo · NCT07804849

• Preventing device-related skin rashes in kids with type 1 diabetes using hydrocolloid vs silicone patches

  This study tests whether silicone-based or hydrocolloid patches help prevent recurring skin irritation from insulin pumps or CGMs in children and teens with type 1 diabetes.

  Recruiting Steno Diabetes Center Copenhagen · Copenhagen · NCT07767461

• AI-assisted remote insulin pump optimization for people with type 1 diabetes

  This study tests an AI-powered tool that suggests insulin pump settings for people with type 1 diabetes, with doctor-approved recommendations delivered to a mobile app.

  Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07732777

• Near-sensor insulin delivery with CGM in people with type 1 diabetes

  A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.

  Recruiting Early Phase 1 ClinSurge Research · Toronto, Ontario · NCT07655076

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.