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

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Severe Obesity

Treatments: Drug: Colesevelam; Drug: Chenodeoxycholic Acid; Other: Water

Study type: Interventional

Funder types: Other

Identifiers

NCT02876484

IJ-G2-16

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Uncomplicated RYGB performed minimum 3 months prior to the study.
• Fasting plasma 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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12 participants in 4 patient groups

Placebo

Experimental group

Description:

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. 25 ml water

Treatment:

Other: Water

Chenodeoxycholic Acid

Experimental group

Description:

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Chenodeoxycholic acid (1250 mg) mixed in 25 ml yoghurt

Treatment:

Drug: Chenodeoxycholic Acid

Colesevelam

Experimental group

Description:

Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.

Treatment:

Drug: Colesevelam

Colesevelam x 2

Experimental group

Description:

plus (on another study day) 3,75 g colesevelam administered the evening before the experiment. Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.

Treatment:

Drug: Colesevelam