Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT01070238
• Lead Sponsor: University of Giessen

Brief 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.

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 Timeline

• Status Verified: 2002-11
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Last Update Submitted: 2010-02-16
• Study First Posted: 2010-02-17
• Last Update Posted: 2010-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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• Women who become pregnant will be withdrawn from the study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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose

Trial Locations

Locations (1)

University Hospital Giessen and Marburg; 🇩🇪 Giessen, Hessen, Germany