Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus

Sponsor

University of Giessen (Other)

Overall Status

Completed

CT.gov ID

NCT01070238

Collaborator

Numico Research (Other)

Location

Study Details

Study Description

Brief Summary

The study was conducted

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Dietary Supplement: Isomaltulose	Phase 1/Phase 2

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 Design

Study Type:

Interventional

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

Outcome Measures

Primary Outcome Measures

Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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