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
  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 Blind (Subject, 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 [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070238

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

No publications provided

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
Study First Received: February 16, 2010
Last Updated: February 16, 2010
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on October 01, 2014