Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

Explorative, Pilot Study With Cross-over Design on the Metabolic Response of Orally Applied Slow Released Carbohydrates in Diabetes Type 2 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070238
• Other study ID #: RA.4240.UKGiessen.021219.B
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 16, 2010
• Last updated: February 16, 2010

Study information

• Verified date: November 2002
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Isomaltulose

Locations

Country	Name	City	State
Germany	University Hospital Giessen and Marburg	Giessen	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
University of Giessen	Numico Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose			Yes