Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus

This study has been completed.

Sponsor:

Collaborator:

Numico Research

Information provided by:

University of Giessen

ClinicalTrials.gov Identifier:

NCT01070238

First received: February 16, 2010

Last updated: NA

Last verified: November 2002

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 16, 2010
Last Updated Date	February 16, 2010
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: February 16, 2010)	Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus
Official Title ^ICMJE	Explorative, Pilot Study With Cross-over Design on the Metabolic Response of Orally Applied Slow Released Carbohydrates in Diabetes Type 2 Patients
Brief Summary	The study was conducted to investigate the superiority of isomaltulose in reduction of postprandial hyperglycemia to describe the kinetics of glucose absorption after a load of isomaltulose to demonstrate the safety of a single load of isomaltulose compared to sucrose in type 2 diabetic patients.
Detailed Description	Epidemiological studies have shown that postprandial hyperglycemia is associated with atherosclerotic diseases. Therefore, therapeutic strategies to reduce postprandial hyperglycemia are desirable. An effective way to improve postprandial glucose level is the use of carbohydrates with low glycemic index. Isomaltulose is a reducing disaccharide occurring naturally in honey and sugar cane juice, including products derived thereof. It is an isomer of sucrose and composed of glucose and fructose linked alpha-1,6 instead of alpha-1,2. Isomaltulose has been reported to be digested more slowly than sucrose. Due to this property, lower and slower increases in blood glucose responses are expected for isomaltulose than sucrose. Early studies have demonstrated attenuated glycemic and insulin responses after isomaltulose ingestion than after sucrose. This study was performed to describe the postprandial glucose metabolism more comprehensively after bolus administration of different doses of isomaltulose compared to sucrose in type 2 diabetic patients.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Dietary Supplement: Isomaltulose
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosis: type 2 diabetes according to WHO/ADA criteria for more than 1 yr Adults aged 18-75 years old HbA1c < 8%, fasting blood glucose < 140 mg/dl For at least 2 months prior to visit 1, subjects must have been on a stable antidiabetic therapy regimen Subjects willing to perform home blood glucose monitoring and to otherwise comply with study protocol requirements Exclusion Criteria: Type 1 diabetes mellitus Pregnant or lactating women or women planning to become pregnant Women who become pregnant will be withdrawn from the study Clinically significant heart, liver, lung, or kidney disease Drug or alcohol abuse Concomitant therapy with systemic glucocorticoids or acarbose Subjects unable to adhere to instructions during the qualification phase
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01070238
Other Study ID Numbers ^ICMJE	RA.4240.UKGiessen.021219.B
Has Data Monitoring Committee	No
Responsible Party	Thomas Linn/Principal Investigator, University of Giessen
Study Sponsor ^ICMJE	University of Giessen
Collaborators ^ICMJE	Numico Research
Investigators ^ICMJE	Not Provided
Information Provided By	University of Giessen
Verification Date	November 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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