The effect of increased salt intake with a meal on blood sugar levels in people without diabetes after weight-loss surgery

Not Applicable

Completed

• Conditions: Prevention of hypoglycaemia in non-diabetic people who have had a gastric bypass; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN12008159
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-23
• Study Completion: 2024-04-30
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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
11. People with allergy or intolerance to the mixed meal tolerance test (eg, milk protein allergy, lactose and gluten intolerance)
12. People following a vegan diet (mixed meal tolerance test not suitable for those following a vegan diet)
13. Other bariatric procedure except of RYGB
14. Previous revisional bariatric surgery
15. Currently pregnant or breastfeeding
16. Patients with history of Type 1 or Type 2 Diabetes
17. Patients with diagnosis of Epilepsy
18. HbA1C >=65% or >=48 mmol/l at screening blood tests
19. Haemoglobin (Hb) <100 g/l at screening blood tests
20. Participating in another research study involving intervention within 3 months of screening
21. Having a formal previous diagnosis of postprandial hypoglycaemia
22. Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia
23. Any concurrent condition, in the judgment of investigator and/or sponsor, that could interfere with the safety and study conduct or interpretation of study results

Study & Design

• Study Type: Interventional
• Study Design: Not specified