Effects of inorganic nitrate on glucose levels in young and older obese subjects

Not Applicable

Completed

• Conditions: Obesity, type 2 diabetes, ageing; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus, Obesity

• Registration Number: ISRCTN42776917
• Lead Sponsor: ewcastle Upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2016 results in https://pubmed.ncbi.nlm.nih.gov/27733522/ (added 23/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-04
• Study Completion: 2014-03-11
• Last Update Posted: 2 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

We aim to recruit:
1. 20 healthy male and female, young (20 ? 35 y) and older (55 - 70 y) obese subjects (BMI Range: 30-40 kg/m2)
2. Subjects will be non-smokers and weight stable.

Exclusion Criteria

1. Current participation in other research clinical studies
2. Vegetarianism (likely to have very high nitrate intake)
3. High physical activity level (may have BMI in obese range but low fat mass)
4. Weight change more than 3.0kg in the last 2 months (important influence on systemic metabolism and vascular function).
5. Active cancer and any diagnosis of malignant cancer in the last 5 years (systemic effects on study outcomes).
6. Diagnosis of chronic and acute metabolic and inflammatory conditions interfering with the study outcome (systemic effects on study outcomes). For example flu, Crohn's Disease, rheumatoid arthritis.
6. Previous diagnosis of type 1 or type-2 diabetes treated with insulin and oral hypoglycaemic agents (modification of regulation of intermediate metabolism).
7. Weight loss medications (sibutramine, orlistat, rimonabant) and history of bariatric surgery (weight loss related changes in systemic metabolism).
8. Drugs: corticosteroids, sildenafil, aspirin, diuretics, beta-blockers, calcium antagonists, anticoagulants, nitrate-derived agents, anti-cholinergic, ace-inhibitors and angiotensin receptors inhibitors and Ca++ channel blockers, statins and any other anti-dyslipidaemic agent (all drugs may have either an effect on NO production or insulin sensitivity via different mechanisms).
9. Subjects on hormonal therapies (oestrogens, thyroxine, progesterone), and psychiatric drugs (antidepressants, sedatives, antipsychotics) will be excluded if dose has been started/changed in the previous three months (make sure that these disorders are under strict control to avoid interference with the study outcomes).
10. Haematological disorders including severe anaemia (Hb< 10mg/dL) (risk for the participant and effects on the study outcomes)
11. Major surgical operations interfering with the study outcomes (systemic effects on study outcomes)
12. Alcohol intake >21 units/week for men and >14 unite/week for women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To test whether the acute administration of an oral dose of nitrate will be associated with a different glycaemic and insulin response compared to placebo.

Secondary Outcome Measures

Name	Time	Method
<br> 1. To investigate the acute effects of inorganic nitrate on endothelial function and biomarkers of NO production.<br> 2. To evaluate the association between insulin resistance, endothelial function with telomere length and telomerase activity.<br> 3. To test whether ageing is a modifier of the association between inorganic nitrate with the primary and secondary outcomes.<br>