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Type 2 Diabetes MellitusNCT00476710

Effects of Colesevelam HCl On Bile Acid Kinetics

An observational study of Type 2 Diabetes Mellitus and Impaired Glucose Tolerance, run by KineMed at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project will compare the amount of bile acids and their kinetics in overweight and obese people with normal glucose metabolism, impaired glucose tolerance and frank type 2 diabetes. We hypothesize that bile acids will behave differently in these groups. Read more about this study

Who is it for?
Ages 40 to 60 yearsHealthy volunteers can take part
What is being tested?
Colesevelam HCl
How many people
36 participants
Where
1 siteUnited States
Study dates
May 2007to Apr 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: overweight and obese people with normal glucose metabolism, impaired glucose tolerance and frank type 2 diabetes

Who may be able to join

  • Have given written informed consent
  • BMI 25-35 kg/m^2, inclusive
  • Normal liver and thyroid function
  • No history of liver, biliary, or intestinal disease
  • Diabetic Subjects
  • Diagnosed Type 2 Diabetes Mellitus
Show all 14Show fewer
  • HbA1C = 6.7-10%
  • Normal Subjects
  • 2 hr OGTT glucose < 140 mg/dL
  • fasting glucose < 100 mg/dL
  • TG < 150 mg/dL
  • HDL cholesterol >= 40 mg/dL
  • Impaired Glucose Tolerance Subjects
  • 2 hr OGTT glucose >= 140 and < 200 mg/dL

Who cannot join

  • T1DM or history of diabetic ketoacidosis
  • treatment with blood pressure lowering therapy that has not been stable for three months before screening
  • colesevelam HCl, cholestyramine, or colestipol treatment for hyperlipidemia within the last three months
  • treatment with thiazolidinedione (TZD) at any time
  • treatment with insulin within past 6 months
  • treatment with antibiotics within last 3 months
Show all 16Show fewer
  • extreme sportsmen
  • treatment with medication affecting liver or intestinal function within the last 3 months
  • allergic or toxic rxn to colesevelam HCl
  • history of dysphagia, swallowing disorders, or intestinal motility disorder
  • Serum Triglycerides > 500 mg/dL at visit 1
  • Serum LDL-C < 60 mg/dL at visit 1
  • any condition or therapy investigator believes not in subjects best interest
  • use of any investigational drug within 30 days before screening
  • chronic treatment with oral corticosteroids at any time or acute treatment within last three months
  • hyperthyroidism or treatment with thyroid hormone/levothyroxine

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Diabetes & Glandular Disease Research Associates, Inc.

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Effects of Colesevelam HCl On Bile Acid Pools And Kinetic Parameters in Normal Subjects, Subjects With Impaired Glucose Tolerance, And Subjects With Type 2 Diabetes Mellitus

This project will compare the amount of bile acids and their kinetics in overweight and obese people with normal glucose metabolism, impaired glucose tolerance and frank type 2 diabetes. We hypothesize that bile acids will behave differently in these groups. We will also explore the effects of Colesevelam HCl, a medicine that lowers LDL cholesterol by binding bile acids, on bile acids in those groups. We hypothesize the drug may have different actions on bile acids in subjects with different degrees of abnormal glucose metabolism.

Read the detailed description

Bile acids, which are synthesized from cholesterol in the liver, play a key role in digestion as they solubilize dietary lipids and aid their absorption in the digestive tract. While for many years bile acids have been characterized by this digestive role, recent research indicates that bile acids play other important roles. Because bile acids have been shown to act in signaling pathways that affect metabolism, there has been renewed interest in investigations of their effects. This study explores potential differences in bile acid kinetics based on insulin resistance or type 2 diabetes at baseline.

Colesevelam HCl is a bile acid sequestrant, which in addition to its primary role in lowering serum LDL-C levels, has secondarily been implicated in lowering blood glucose levels. This study explores the relationship between insulin resistance and type 2 diabetes and changes in bile acid pool sizes and kinetics with colesevelam treatment. Isotopically labeled bile acids will be administered to subjects before and after treatment with colesevelam and comparisons will be made in bile acid pool size, fractional turnover rate, and synthesis rate in the three study groups.

Being tested
Colesevelam HCl
Keywords
Type 2 diabetes mellitus, Bile acid, Stable isotope, Colesevelam HCl, Impaired Glucose Tolerance
Medical subject headings
Diabetes Mellitus, Type 2, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colesevelam HClDrug

Study groups in NCT00476710
Study groupRoleWhat they receive
Normal Glucose MetabolismOverweight and obese individuals that have normal glucose metabolism and their response to Colesevelam HCl
Receives: Drug: Colesevelam HCl
Impaired Glucose ToleranceOverweight and obese individuals that have impaired glucose tolerance and their response to Colesevelam HCl
Receives: Drug: Colesevelam HCl
Frank type 2 diabetesOverweight and obese individuals that have frank type 2 diabetes and their response to Colesevelam HCl
Receives: Drug: Colesevelam HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bile Acid Pool Size and Kinetic Parameters

    Measured: 60 days of treatment

Secondary outcomes (1)

  1. Resting Metabolic Rate

    Measured: 60 days of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00476710
Sponsor's protocol ID
KM-11B
Status last verified
Mar 2015
First submitted
18 May 2007
Last updated
1 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Grundy SM, Ahrens EH Jr, Salen G. Interruption of the enterohepatic circulation of bile acids in man: comparative effects of cholestyramine and ileal exclusion on cholesterol metabolism. J Lab Clin Med. 1971 Jul;78(1):94-121. No abstract available.

    PubMed 5569253

  • Shepherd J, Packard CJ, Bicker S, Lawrie TD, Morgan HG. Cholestyramine promotes receptor-mediated low-density-lipoprotein catabolism. N Engl J Med. 1980 May 29;302(22):1219-22. doi: 10.1056/NEJM198005293022202.

    PubMed 7366673

  • Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clin Ther. 2007 Jan;29(1):74-83. doi: 10.1016/j.clinthera.2007.01.003.

    PubMed 17379048

  • Abrams JJ, Ginsberg H, Grundy SM. Metabolism of cholesterol and plasma triglycerides in nonketotic diabetes mellitus. Diabetes. 1982 Oct;31(10):903-10. doi: 10.2337/diab.31.10.903.

    PubMed 6759223

  • Andersen E, Karlaganis G, Sjovall J. Altered bile acid profiles in duodenal bile and urine in diabetic subjects. Eur J Clin Invest. 1988 Apr;18(2):166-72. doi: 10.1111/j.1365-2362.1988.tb02408.x.

    PubMed 3133222

  • Bennion LJ, Grundy SM. Effects of diabetes mellitus on cholesterol metabolism in man. N Engl J Med. 1977 Jun 16;296(24):1365-71. doi: 10.1056/NEJM197706162962401.

    PubMed 870827

  • Hulzebos CV, Renfurm L, Bandsma RH, Verkade HJ, Boer T, Boverhof R, Tanaka H, Mierau I, Sauer PJ, Kuipers F, Stellaard F. Measurement of parameters of cholic acid kinetics in plasma using a microscale stable isotope dilution technique: application to rodents and humans. J Lipid Res. 2001 Nov;42(11):1923-9.

    PubMed 11714862

  • Brufau G, Stellaard F, Prado K, Bloks VW, Jonkers E, Boverhof R, Kuipers F, Murphy EJ. Improved glycemic control with colesevelam treatment in patients with type 2 diabetes is not directly associated with changes in bile acid metabolism. Hepatology. 2010 Oct;52(4):1455-64. doi: 10.1002/hep.23831.

    PubMed 20725912

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus and Impaired Glucose Tolerance, run by KineMed at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bile Acid Pool Size and Kinetic Parameters (time frame: 60 days of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00476710, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.

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