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Clinical Trials/ISRCTN12008159
ISRCTN12008159
Completed
未知

The effect of increased sodium intake with a carbohydrate-rich meal on glucose homeostasis in subjects without diabetes after bariatric surgery: A proof-of-concept, randomised, open-label, crossover study

niversity of Leicester0 sites12 target enrollmentJuly 23, 2020

Overview

Phase
未知
Intervention
Not specified
Conditions
Prevention of hypoglycaemia in non-diabetic people who have had a gastric bypass
Sponsor
niversity of Leicester
Enrollment
12
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 23, 2020
End Date
April 30, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Leicester

Eligibility Criteria

Inclusion Criteria

  • 1\. Aged \>\=18 years old but less than 75 years old
  • 2\. Subjects \>\=1 year after gastric bypass (RYGB)
  • 3\. Able to understand written and spoken English
  • 4\. Able to give informed consent

Exclusion Criteria

  • 1\. Use of any glucose\-lowering medication (including insulin)
  • 2\. Adrenal insufficiency and/or substitution with glucocorticoids
  • 3\. eGFR \<\=60 ml/min/173 m²
  • 4\. Recent active infection (an active infection will be any infection over the last 10 days)
  • 5\. Current use of steroids
  • 6\. Known liver cirrhosis or ALT \>2 times above upper normal limit
  • 7\. Known primary or secondary hyperaldosteronism
  • 8\. Moderate or severe hypertension during screening visit (Systolic Blood Pressure \>160 mmHg as average of 3 measurements)
  • 9\. Established diagnosis of congestive heart failure
  • 10\. Significant peripheral oedema on clinical examination at screening visit

Outcomes

Primary Outcomes

Not specified

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