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Completed

NCT Number: NCT02871882

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Structural of metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
  • Irritable bowel syndrome
  • Bristol stool type classification 4-7 per Bowel Disease questionnaire.
  • Subjects with other treatment for type 2 diabetes mellitus.
  • Subjects with HbA1c > 8%
  • Females who are pregnant or breastfeeding
  • Concomitant use of appetite suppressants, orlistat, phentermine-topiramate ER or lorcaserin.
  • 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.
  • Subjects who have donated blood or plasma in the past 8 weeks.
  • Subjects who have participated in another study within the past 30 days.

Treatment and study plan

Gastric Emptying test

Radiation

participants eat a standardized meal labeled with radioactive markers (99mTc DTPA [diethylenetriaminepentaacetic acid] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.

Mixed Oral Glucose Tolerance test

Other

Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.

Conjugated bile acids sodium

Drug

500 mg tablets taken orally twice daily for 28 (+/- 4) days

Other names: Ox Bile extract

Placebo

Other

Placebo tablets taken orally twice daily for 28 (+/- 4) days

Primary outcomes

  1. Change in Postprandial Glucose

    Time frame: baseline to 1 month

    Measurement of the glucose concentration in the bloodstream 6 hours after eating a meal

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Satiogen Pharmaceuticals, Inc.

Registry information

Official study title

Effect of Delayed-Release Bile Acid on Insulin Sensitivity, Gastric Emptying and Body Weight in Overweight or Obese Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2016
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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