| Trial ID: | L1939 |
| Source ID: | NCT00596427
|
| Associated Drug: |
Colesevelam Hcl
|
| Title: |
Mechanisms of Glucose Lowering Effect of Colesevelam HCl
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00596427/results
|
| Conditions: |
Diabetes
|
| Interventions: |
DRUG: Colesevelam HCL|DRUG: Placebo
|
| Outcome Measures: |
Primary: Fasting Endogenous Glucose Production (EGP), Changes from baseline of fasting EGP after 12 weeks of placebo or colesevelam treatment., baseline and 12 weeks|Fasting Gluconeogenesis, Change from baseline of fasting gluconeogenesis after 12 weeks of placebo or colesevelam treatment., baseline and 12 weeks|Fasting Glycogenolysis, Change from baseline of fasting glycogenolysis after 12 weeks of placebo or colesevelam treatment., baseline and 12 weeks|Rate of Appearance of Exogenous Glucose (Glucose Absorption), Change from baseline of the rate of appearance of oral glucose after 12 weeks of placebo or colesevelam treatment. Mean of values obtained between 0 and 300 min is reported., baseline and 12 weeks | Secondary: Total Glucagon-like Peptide (GLP-1) Area Under the Curve (AUC), Changes from baseline of total GLP-1 AUC after 12 weeks of placebo or colesevelam treatment. AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes, baseline and 12 weeks|Total Glucose-dependent Insulinotropic Polypeptide (GIP) AUC, Changes from baseline of total GIP-1 AUC after 12 weeks of placebo or colesevelam treatment. AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes, baseline and 12 weeks|Fasting Fractional De Novo Lipogenesis (DNL), Changes from baseline in fasting fractional DNL after 12 weeks of colesevelam or placebo treatment were calculated. Fractional DNL represents the fraction of palmitate in very-low density lipoproteins-triglycerides (VLDL-TG) that was newly synthesized., baseline and 12 weeks|Fasting Fractional Cholesterol Synthesis, Changes from baseline in fasting fractional cholesterol synthesis after 12 weeks of colesevelam or placebo treatment. Fractional Cholesterol synthesis represents the fraction of free cholesterol in plasma that was newly synthesised., baseline and 12 weeks|Postprandial Fractional Cholic Acid Synthesis, Changes from baseline in fractional cholic acid synthesis after 12 weeks of colesevelam or placebo treatment were evaluated. Fractional cholic acid synthesis represents the relative amount of cholic acid that is made from newly synthesised cholesterol., baseline and 12 weeks|Glucagon AUC, Changes from baseline of glucagon AUC after 12 weeks of placebo or colesevelam treatment. AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes, baseline and 12 weeks | Other: Glycosylated Hemoglobin (HbAlc), Changes from baseline of HbA1c after 12 weeks of placebo or colesevelam treatment., baseline and 12 weeks|Glucose AUC, Changes from baseline of glucose AUC after 12 weeks of placebo or colesevelam treatment. AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes, baseline and 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Carine Beysen
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2007-11
|
| Completion Date: |
2009-04
|
| Results First Posted: |
2012-10-12
|
| Last Update Posted: |
2012-10-12
|
| Locations: |
Diablo Clinical Research, Inc, Walnut Creek, California, 94598, United States|Clinical Pharmacology of Miami, Inc, Miami, Florida, 33014, United States|Diabetes & Glandular Disease Research Associates, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00596427
|
