NCT05011682

The Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric Bypass Surgery

The Effect of Nutrition and Medical Therapy on Post-bariatric Hypoglycemia Patients 2-4 Years After a Roux-en-Y Gastric Bypass: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Helse Nord-Trøndelag HF · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery. The study is largely inspired by the findings presented in the meta-analyses from Joslin Diabetes Center, where a treatment strategy is proposed to reduce the symptoms of PBH. This treatment strategy is mainly based on clinical observations and experience, while there is little or no objective data to support that this strategy improves PBH. The data from this pilot study can then be used to set up larger studies where a conclusion on treatment of PBH may be drawn.

Conditions

• Hypoglycemia
• Obesity, Morbid

Interventions

Type	Name	Description
BEHAVIORAL	Regular diet	participant's usual diet during 2 weeks
BEHAVIORAL	10-point nutrition plan	controlled portions of low glycemic index carbohydrates, avoidance of rapidly absorbed carbohydrates, adjustment of timing of meals and snacks, and attention to personal and cultural barriers to implementation

Timeline

• Start date: 2021-08-27
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2021-08-18
• Last updated: 2023-01-18

Locations

1 site across 1 country: Norway