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

• Sponsor: Hvidovre University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02876484
• Collaborator: University of Copenhagen (Other)
• Enrollment: 12
• Location: 1
• Arms: 4
• Duration (Months): 53
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Obesity	Drug: Colesevelam; Drug: Chenodeoxycholic Acid; Other: Water	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Chenodeoxycholic Acid and Colesevelam on GLP-1 Secretion, During a Meal, After Roux-en-Y Gastric Bypass
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Placebo Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. 25 ml water	Other: Water
Experimental: Chenodeoxycholic Acid Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Chenodeoxycholic acid (1250 mg) mixed in 25 ml yoghurt	Drug: Chenodeoxycholic Acid
Experimental: Colesevelam 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.	Drug: Colesevelam
Experimental: Colesevelam x 2 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.	Drug: Colesevelam

Outcome Measures

Primary Outcome Measures

1. GLP-1 secretion (evaluated by iAUC) [-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes after mixed meal]

Secondary Outcome Measures

1. Glucose levels [-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes]

2. Insulin secretion [-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes]

3. PYY secretion [-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes]

4. Bile acids/FGF19 concentrations [-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes]

5. Appetite measurements (VAS-score) [0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes]

6. PCM levels [Baseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes]

7. C-peptide secretion [Baseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes]

8. Glucagon secretion [Baseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes]

9. GIP secretion [0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes]

10. CCK secretion [0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes]

11. Ghrelin [0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes]

12. Total bile acid secretion [0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hvidovre University Hospital	Hvidovre		Denmark	DK-2650

Sponsors and Collaborators

• Hvidovre University Hospital
• University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Saur Svane, MD, Hvidovre University Hospital
• ClinicalTrials.gov Identifier: NCT02876484
• Other Study ID Numbers: IJ-G2-16
• First Posted: Aug 23, 2016
• Last Update Posted: Nov 30, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Obesity, Morbid; Chenodeoxycholic Acid; Colesevelam Hydrochloride

Study Results

No Results Posted as of Nov 30, 2020