Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of the present study is to determine if use of dietary supplement tauroursodeoxycholic acid enhances insulin-stimulated leg blood flow and glucose disposal.
Detailed description
The notion that cellular stress lowers insulin-induced vasodilation is largely founded on ex vivo studies and experiments in rodents. However, it remains unknown if maintenance of cellular function with the use of dietary supplement tauroursodeoxycholic acid enhances vascular function in humans. The investigators test the hypothesis that daily administration of this dietary supplement enhances vascular function, particularly, insulin-stimulated leg blood flow and glucose disposal.
Interventions
DIETARY_SUPPLEMENTTauroursodeoxycholic acid
Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks.
DIETARY_SUPPLEMENTPlacebo
Taking daily placebo capsules for 4 weeks.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Participants are not told which are placebo or tauroursodeoxycholic acid capsules
Intervention model description
Single-blinded randomized crossover study
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes diagnosed by primary physician * Body mass index less then 43 kg/m2
Exclusion criteria
* Recent weight gain or loss (\>5% body weight in the last 3 months) * Pregnancy * Consumption of \>14 alcoholic beverages per week * Changes in the medication use or dose within the last 3 months * Known cardiovascular or pulmonary disease * Taking medication for advanced retinopathy or neuropathy * Taking prescription anticoagulants * Nicotine use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood flow | Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid | Blood flow response during insulin clamp |
| Vascular function | Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid | Flow-mediated dilation |
| Insulin resistance | Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid | Glucose disposal rate during insulin clamp |
| Glucose tolerance | Once at 4 weeks after the start of placebo and once at 4 weeks after the start of tauroursodeoxycholic acid | Glucose response to an oral glucose tolerance test |
Countries
United States
Outcome results
None listed