Sponsor study identifier
interventional
1
1 country
1
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)The purpose of this study is to determine whether addition of 1 or 2 medicines after gastric banding can improve remission of type 2 diabetes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2012
Actual (reported)May 14, 2012
Actual (reported)June 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 2014
Actual (reported)June 2014
Actual (reported)Type 2 diabetes remission
Hemoglobin a1c will be used to assess type 2 diabetes remission.
baseline, 1 and 4 months post-randomization
Whole body insulin sensitivity
baseline, 1 and 4 months post-randomization
GLP-1 response
Baseline, 1 and 4 months post-randomization
First Phase Insulin secretion
Baseline, 1 and 4 months post-randomization
Liraglutide will be started at 0.6 mg injected subcutaneously daily for 1 week and then increased as tolerated to 1.2 mg and then a 1.8 mg daily.
Orlistat will be started initially at a dose of 60 mg taken with the evening meal. Additional doses will be added at breakfast or lunch every 1-2 weeks as tolerated. The patient will be advised to skip drug dosing if little or no fat is contained in the meal. Target dose will 60 mg three times a day and the patients will be advised to take a multivitamin 2 hours before or after Orlistat addition to ensure adequate nutrition.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Liraglutide + Orlistat
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordBrody School of Medicine at East Carolina University
Greenville, North Carolina, 28590, United States
Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
1 participants (actual enrollment reported by the registry).
First Submitted
May 10, 2012
First Posted
May 14, 2012
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Impact of Liraglutide on Endothelial Function and Microvascular Blood Flow in Type 2 Diabetes Mellitus
Liraglutide will be started at 0.6 mg injected subcutaneously daily for 1 week and then increased as tolerated to 1.2 mg and then a 1.8 mg daily. Patients not tolerating a higher dose will be allowed to remain on the lower dose as long they tolerate the lower. Following titration of Liraglutide to a maximum tolerated dose, Orlistat will be started initially at a dose of 60 mg taken with evening meal. Additional doses will be added at breakfast or lunch every 1-2 weeks as tolerated. The patient will be advised to skip drug dosing if little or no fat is contained in the meal. Target dose will 60 mg three times a day.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
February 5, 2018
Record last verified: 2018-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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