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

Not Applicable

Completed

• Conditions: Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Cardiovascular disease, Hypertension, Diabetic Control, Nutrition, Pre Diabetes; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN25003627
• Lead Sponsor: King's College London (UK)

Brief Summary

2017 Abstract results in https://www.ncbi.nlm.nih.gov/pubmed/28935045 abstract (added 04/06/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31833569/ (added 24/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33982797/ (added 11/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-31
• Study Completion: 2014-06-02
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 126

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

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 < 45 mls per minute (approximately - i.e. if one test is around 43 and another is around 46 the average of around 45 is acceptable)
5. Objective renal function tests for creatinine > 180 umol/l (when eGFR will be < 45 mls/ min).
6. All other aspects of diabetic control will be acceptable except gross disturbances of glycaemia with HbA1c > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified