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Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01070238
First Posted: February 17, 2010
Last Update Posted: February 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Numico Research
Information provided by:
University of Giessen
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Dietary Supplement: Isomaltulose Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Explorative, Pilot Study With Cross-over Design on the Metabolic Response of Orally Applied Slow Released Carbohydrates in Diabetes Type 2 Patients

Resource links provided by NLM:


Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070238


Locations
Germany
University Hospital Giessen and Marburg
Giessen, Hessen, Germany, 35392
Sponsors and Collaborators
University of Giessen
Numico Research
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Linn/Principal Investigator, University of Giessen
ClinicalTrials.gov Identifier: NCT01070238     History of Changes
Other Study ID Numbers: RA.4240.UKGiessen.021219.B
First Submitted: February 16, 2010
First Posted: February 17, 2010
Last Update Posted: February 17, 2010
Last Verified: November 2002

Keywords provided by University of Giessen:
Isomaltulose
Slow Released Carbohydrates
Postprandial Glucose Metabolism
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases