A study to test whether spironolactone and dietary nitrate (as beetroot juice) alter blood vessel stiffness in Type 2 diabetes

A study to test whether spironolactone and dietary nitrate (as beetroot juice) (I) compared to controls, alter blood vessel function, measured as the cardiac-ankle vascular index (O) or as arterial pulse wave velocity (O) in Type 2 diabetes (P): a randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN25003627

Enrollment

120

Registered

2013-01-31

Start date

2013-02-01

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Diabetes Research Network

Interventions

Drugs: Spironolactone at 12.5 mg titrated up to 25 mg or 50mg daily for 6 months, or up to 1 year if subject are willing. Doxazosin at 4mg, titrated up to 8mg and 16mg for the same per

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Anyone (male or female, age 18-80) with ?diagnosed? type 2 Diabetes or at risk of type 2 Diabetes (being overweight BMI >= 27 kg/m2) or found to have impaired glucose tolerance by fasting glycaemia or by glucose tolerance testing will be eligible. Please see under exclusion criteria for limits to this 2. Participants need to be able to understand the protocol and be willing to comply with it

Exclusion criteria

Exclusion criteria: 1. Ongoing (chronic) illness of any type interfering with patient ability to participate 2. Major complications restricting mobility including active foot ulceration or amputation may be exclusion criteria, but only if the patient feels they cannot manage 3. Previous adverse reactions to Spironolactone or Doxazosin. (If patients are already on either of these, we can discuss alternatives) 4. Renal function by eGFR 180 umol/l (when eGFR will be 11% and fasting random glucose > 12mmol/l. Those will not be indications to withdraw patients, but only as exclusions for entry (& once improved can become eligible). 7. For women: being pregnant or breastfeeding for the duration of the study

Design outcomes

Primary

Measure	Time frame
Vascular function measured as CAVI (Cardio-Ankle Vascular index); Timepoint(s): baseline visit, 2 weeks, 2,3,6,12 months	—

Secondary

Measure	Time frame
1. Capillary density; Timepoint(s): baseline, 3 and 6 months 2. Hormones related to diabetes and hypertension; Timepoint(s): baseline, 2 weeks, 2, 3, 6, 12 months 3. PWV (Pulse Wave Velocity) in relation to changes in BP (Blood Pressure); Timepoint(s): Baseline, 2 weeks, 2, 3, 6, 12 months 4. Urinary Sodium, Potassium; Timepoint(s): baseline, 2 weeks, 2,3, 6,12 months	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026