NCT04118374Completed
A Study to Determine Iatrogenic Hyperinsulinemia's Contribution to Insulin Resistance and Endothelial Dysfunction in Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 28 Oct 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 2 Oct 2019
- Start date
- 24 Nov 2021
- Primary completion date
- 21 Jun 2024
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Type 1 diabetes
- NCT number
- NCT04118374
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 24 Nov 2021 to the primary completion date, 21 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- HCT \<35%
- medications
- any antioxidant vitamin supplement (\<2 weeks before STUDY visit)
Other illness
- New York Heart Association Class II-IV cardiac functional status
- any diabetes medication except insulin
Lab values
- diabetes comorbidities (\>= 1 trip to emergency department for poor glucose control in the past 6 months,
- eGFR by MDRD equation of \<60 mL/min/1.73m\^2
- AST or ALT \> 2.5 times the upper limit of normal
Other
- severe hypoglycemia : \>/= 1 episode in the past 3 months
- SBP \> 140 and DBP \> 100 mmHg,
- any systemic glucocorticoid
- any antipsychotic
- atenolol, metoprolol, propranolol
- niacin
- any thiazide diuretic
- any OCP with \> 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
Related publications
- A one-week reduced-carbohydrate diet lowers insulin requirements and shifts the IGF axis with no detectable short-term change in endothelial function in a randomized, crossover trial of adults with type 1 diabetes.Cardiovasc Diabetol Endocrinol Rep · 2026 · PMID 41882799
This page is information, not medical advice. Discuss any trial with your doctor.