Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Overweight; Obese; Type 2 Diabetes Mellitus

Treatments: Radiation: Gastric Emptying test; Other: Placebo; Drug: Conjugated bile acids sodium; Other: Mixed Oral Glucose Tolerance test

Study type: Interventional

Funder types: Other

Identifiers

NCT02871882

15-007765

Details and patient eligibility

About

To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.

Full description

This is a single-center, placebo-controlled, parallel-group, single dose, randomized, controlled trial. Participants will receive 28 days (+/- 4 days) of treatment to study the effect of delayed (ileocolonic)-release ox bile extract 500 mg BID (twice daily) on insulin sensitivity, gastric emptying of liquids and solids (measured by scintigraphy) and weight loss I overweight and obese type 2 diabetic subjects. Participants will be receiving therapy with DPP4 inhibitors alone or in combination with metformin. Blood samples will be collected at defined times to measure glycemia, FGF-19 and incretins (GLP-1 [glucagon-like peptide-1], OXM [oxyntomodulin], PYY 3-36 [peptide YY]) fasting levels and responses to the meal.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Overweight or obese subjects with BMI > 30 kg/m2 with type 2 diabetes mellitus taking DPP4 inhibitors alone or in combination with metformin.
2. Women of childbearing potential will have a negative pregnancy test before initiation of medication and within 48 hours of receiving radioisotope.

Exclusion criteria

1. Structural of metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
2. Irritable bowel syndrome
3. Bristol stool type classification 4-7 per Bowel Disease questionnaire.
4. Subjects with other treatment for type 2 diabetes mellitus.
5. Subjects with HbA1c > 8%
6. Females who are pregnant or breastfeeding
7. Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or lorcaserin.
8. Subjects who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than type 2 diabetes mellitus), and unstable psychiatric disease.
9. Subjects who have donated blood or plasma in the past 8 weeks.
10. Subjects who have participated in another study within the past 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Ox bile extract

Active Comparator group

Description:

Ox bile extract 500 mg tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests

Treatment:

Other: Mixed Oral Glucose Tolerance test

Radiation: Gastric Emptying test

Drug: Conjugated bile acids sodium

Placebo

Placebo Comparator group

Description:

Matching placebo tablets taken orally twice daily for 28 (+/- 4) days Gastric Emptying test, Waist and hip measurements, Mixed oral glucose tolerance test, Blood tests

Treatment:

Other: Mixed Oral Glucose Tolerance test

Radiation: Gastric Emptying test

Other: Placebo