Status:
COMPLETED
A Study to Determine Iatrogenic Hyperinsulinemia's Contribution to Insulin Resistance and Endothelial Dysfunction in Type 1 Diabetes
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 (Ai...
Detailed Description
Insulin resistance (IR) is consistently found in patients with type 1 diabetes (T1DM) and pathophysiologically links T1DM with atherosclerotic disease. IR and nascent atherosclerosis, as characterized...
Eligibility Criteria
Inclusion
- 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
- 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 \<60 mL/min/1.73m\^2
- AST or ALT \> 2.5 times the upper limit of normal
- HCT \<35%
- medications
- any antioxidant vitamin supplement (\<2 weeks before STUDY visit)
- 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
- any diabetes medication except insulin
Key Trial Info
Start Date :
November 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04118374
Start Date
November 24 2021
End Date
June 21 2024
Last Update
October 28 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232