Effects of Bile Acids 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: Ursodeoxycholic Acid; Other: Water

Study type: Interventional

Funder types: Other

Identifiers

NCT02340247

SN-GALDE-14

Details and patient eligibility

About

The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.

Enrollment: 11 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Uncomplicated RYGB performed minimum 3 months prior to the study.
• Fasting plasma glucose < 7.0mM, HbA1c < 48mmol/mol 3 months after RYGB.

Exclusion criteria

• Fasting plasma glucose > 7.0mM, HbA1c > 48mmol/mol 3 months after RYGB.
• Dysregulated hypothyroidism, 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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 3 patient groups

Placebo

Experimental group

Description:

150mL water

Treatment:

Other: Water

Ursodeoxycholic acid

Experimental group

Description:

Ursodeoxycholic acid (750mg) dissolved in 150mL water

Treatment:

Drug: Ursodeoxycholic Acid

Chenodeoxycholic acid

Experimental group

Description:

Chenodeoxycholic acid (1250mg) dissolved in 150mL water

Treatment:

Drug: Chenodeoxycholic Acid