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

February 16, 2010
February 16, 2010
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Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus
Explorative, Pilot Study With Cross-over Design on the Metabolic Response of Orally Applied Slow Released Carbohydrates in Diabetes Type 2 Patients

The study was conducted

  1. to investigate the superiority of isomaltulose in reduction of postprandial hyperglycemia
  2. to describe the kinetics of glucose absorption after a load of isomaltulose
  3. to demonstrate the safety of a single load of isomaltulose compared to sucrose in type 2 diabetic patients.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Type 2 Diabetes
Dietary Supplement: Isomaltulose
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01070238
RA.4240.UKGiessen.021219.B
No
Thomas Linn/Principal Investigator, University of Giessen
University of Giessen
Numico Research
Not Provided
University of Giessen
November 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP