Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Isomaltulose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Isomaltulose|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Isomaltulose, Slow Released Carbohydrates, Postprandial Glucose Metabolism, Type 2 diabetes