Sex-related Differences in Arterial Stiffness in Type 2 Diabetics: Role of Uric Acid
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 55 - 75 |
| Updated: | 12/21/2018 |
| Start Date: | November 1, 2018 |
| End Date: | September 30, 2021 |
| Contact: | Camila Manrique Acevedo, MD |
| Email: | manriquec@health.missouri.edu |
| Phone: | 573-8820999 |
Two separate interventions will be undertaken with the primary outcome of improving pulse
wave velocity. Initially, age and BMI-matched men and post-menopausal women, all with type 2
diabetes, will be treated with allopurinol (20 men, 20 women) for 6 months, in order to
reduce serum uric acid (SUA) concentrations to 6 mg/dL relative to placebo (10 men, 10
women). In a second intervention, dietary fructose will be restricted for a period of 6
months in type 2 diabetes (T2D) subjects who will maintain a stable weight (20 men, 20
women). At the beginning and end of both studies, measures of arterial stiffness will be
combined with assessments of endothelial function (flow-mediated dilation and insulin
stimulated leg blood flow), measurements of systemic inflammation and oxidative stress.
wave velocity. Initially, age and BMI-matched men and post-menopausal women, all with type 2
diabetes, will be treated with allopurinol (20 men, 20 women) for 6 months, in order to
reduce serum uric acid (SUA) concentrations to 6 mg/dL relative to placebo (10 men, 10
women). In a second intervention, dietary fructose will be restricted for a period of 6
months in type 2 diabetes (T2D) subjects who will maintain a stable weight (20 men, 20
women). At the beginning and end of both studies, measures of arterial stiffness will be
combined with assessments of endothelial function (flow-mediated dilation and insulin
stimulated leg blood flow), measurements of systemic inflammation and oxidative stress.
Sedentary, overweight and obese subjects diagnosed with T2D, age > 55 years old, will be
recruited from the local community, via the University of Missouri's Endocrinology Clinic and
the primary care clinics. During screening, and after consent, anthropometrics (waist
circumference and body composition) will be obtained and fasting blood will be drawn for
serum chemistries, A1c, a lipid panel, complete blood count, thyroid, liver and kidney
function. Subjects will complete lifestyle questionnaires, review the pretest exercise and
alcohol restrictions with the dietitian, and will be given a chance to acclimate to the
hooded mode of the metabolic cart to prepare for future energy-expenditure
measurements.Following screening, eligible subjects will be assigned to one of the three
groups (allopurinol, placebo or fructose restriction). Allopurinol will be titrated to
achieve a SUA of < 6 mg/dL. Along with placebo, this arm of the study is double-blinded. A
separate group of men and women will be assigned to the fructose-restriction study in which
dietary fructose is replaced by starch and body weight is held constant. The subjects in this
group will not be blinded to the dietary treatment but the staff making measurements will be.
Subjects in the three groups will be matched for age and BMI.
recruited from the local community, via the University of Missouri's Endocrinology Clinic and
the primary care clinics. During screening, and after consent, anthropometrics (waist
circumference and body composition) will be obtained and fasting blood will be drawn for
serum chemistries, A1c, a lipid panel, complete blood count, thyroid, liver and kidney
function. Subjects will complete lifestyle questionnaires, review the pretest exercise and
alcohol restrictions with the dietitian, and will be given a chance to acclimate to the
hooded mode of the metabolic cart to prepare for future energy-expenditure
measurements.Following screening, eligible subjects will be assigned to one of the three
groups (allopurinol, placebo or fructose restriction). Allopurinol will be titrated to
achieve a SUA of < 6 mg/dL. Along with placebo, this arm of the study is double-blinded. A
separate group of men and women will be assigned to the fructose-restriction study in which
dietary fructose is replaced by starch and body weight is held constant. The subjects in this
group will not be blinded to the dietary treatment but the staff making measurements will be.
Subjects in the three groups will be matched for age and BMI.
Inclusion Criteria:
- Men and post-menopausal women older > 55 years at randomization and with type 2
diabetes diagnosed per ADA 2018 criteria > 3 months ago.
- Women: no menstrual periods for > 6 mo.
- BMI between 25.1 and 40 kg/m2.
- A1C level obtained <3 mo before randomization 6.5-8%
- Stable glucose lowering therapy for at least 3 months.
- SUA > 7 mg/dL for women and men.
- Habitual diets containing >13% from added sugars.
Exclusion Criteria:
- Known cardiovascular disease (CVD), unstable angina, abnormal thyroid tests or liver
disease, renal disease (GFR <60) and hyperparathyroidism.
- Use of diuretics or a azathioprine.
- A1C > 8%
- Habitual diets with low content of added sugars (<5% total energy)
- Occasional or regular tobacco use.
- History of gout or uncontrolled hypertension.
- Weight loss >10% in the past 6 months
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