N/A N=12 Randomized Treatment

A Study to Determine Iatrogenic Hyperinsulinemia's Contribution to Insulin Resistance and Endothelial Dysfunction in Type 1 Diabetes

Diabetes Mellitus, Type 1

Bottom Line

View on ClinicalTrials.gov: NCT04118374 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: Change in Insulin Sensitivity Assessed as Glucose Infusion Rates — 8.6; 8.1 mg/kg FFM/min — p=<0.01

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Standard Carb Diet (Other); Low Carb Diet (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Insulin Sensitivity Assessed as Glucose Infusion Rates	8.6; 8.1	<0.01 sig

Summary

The investigators will test the hypothesis that reducing insulin doses using a low carbohydrate diet (LCD) will be associated with with improved insulin sensitivity (Aim 1) and blood vessel health (Aim 2).

Eligibility Criteria

Inclusion Criteria

Age: 18-60
HbA1c: 5.6-9.0%
Insulin delivery: must be on an insulin pump
Glucose Monitor: must use a continuous glucose monitor (CGM)
BMI 18-33 kg/m^2
Body Mass >/= 50 kg ( 110 lbs)

Exclusion Criteria

severe hypoglycemia : >/= 1 episode in the past 3 months
diabetes comorbidities (>= 1 trip to emergency department for poor glucose control in the past 6 months,
New York Heart Association Class II-IV cardiac functional status
SBP > 140 and DBP > 100 mmHg,
eGFR by MDRD equation of 2.5 times the upper limit of normal
HCT 35 mcg ethinyl estradiol,
growth hormone
any immunosuppressant
any antihypertensive
any antihyperlipidemic

other:

pregnancy
Tanner stage < 5
peri or postmenopausal woman
active smoker
gluten-free diet requirement

Additional exclusion criteria for T1DM subjects

any diabetes medication except insulin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04118374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.