Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes

Study Overview
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Brief Summary
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In animal models and retrospective studies, certain food components such as sugars and fiber have been detected as potential agents to influence development and progress of type 2 diabetes. The DiNA study prospectively investigates, if non-soluble non-fermentable fibers (vs. soluble ones) and galactose (vs. palatinose) are capable to improvement metabolic parameters in patients with long-term type 2 diabetes and intensive insulin treatment.

Official Title
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Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes, insulin-dependent high insulin resistance Exclusion Criteria: accompanying disease, medication or metabolic disorder, which interact with glucose metabolism or eating behavior (e.g. renal insufficiency, major cardial insuffiency, untreated hypothyreosis, corticoid treatment, depression and other psychiatric disorders...)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pure galactose<br>5 grams of galactose, three times a day with the main meals, duration: 4 weeks | Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)<br> <br> |
| Placebo Comparator: pure palatinose<br>5 grams of palatinose, three times a day with the main meals, duration: 4 weeks | Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)<br> <br> |
| Placebo Comparator: soluble non-fermentable fibers<br>5 grams of soluble non-fermentable fibers, three times a day with the main meals, duration: 4 weeks | Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)<br> <br> |
| Active Comparator: non-soluble non-fermentable fibers<br>5 grams of non-soluble non-fermentable fibers, three times a day with each main meal, duration: 4 weeks | Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic improvement of type 2 diabetes | metabolic improvement of type 2 diabetes, as to be shown via hyperinsulinemic-euglycaemic clamp, mixed-meal test and daily demand of insulin units | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, nutrition, fibers