ClinicalTrials.Veeva

Menu

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

Mayo Clinic logo

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

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

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems