Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Severe Obesity

Treatments: Drug: Chenodeoxycholic Acid; Drug: Colesevelam

Study type: Interventional

Funder types: Other

Identifiers

NCT02952963

IJ-GALDE3-16

Details and patient eligibility

About

The purpose of this study is to examine the efffects of bile acid and bile acids sequestrants on GLP-1 secretion, in patients after Roux-en-Y gastric bypass.

Enrollment: 8 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Uncomplicated RYGB performed minimum 3 months prior to the study.
• Fasting glucose < 7,0 mM, HbA1c < 48 mmol/mol 3 months after RYGB

Exclusion criteria

• Fasting plasma glucose > 7,0 mM, HbA1c > 48 mmol/mol 3 months after RYGB
• Dysregulated thyroid diseases, use of antithyroid treatment.
• Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.
• Complications to RYGB. Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake)
• Cholecystectomy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Chenodeoxycholic Acid

Experimental group

Description:

Chenodeoxycholic Acid (1250 mg) dissolved in 200 ml water. Here after 50 ml clean water.

Treatment:

Drug: Chenodeoxycholic Acid

Chenodeoxycholic Acid and Colesevelam

Experimental group

Description:

Chenodeoxycholic Acid (1250 mg) and Colesevelam (3,75 g) dissolved in 200 ml water. Here after 50 ml clean water.

Treatment:

Drug: Chenodeoxycholic Acid

Drug: Colesevelam