Diabetes Nutrition Algorithms - Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes (DiNA)

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.

Study Type: Interventional

Allocation: Randomized

Endpoint Classification: Safety/Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary Purpose: Treatment

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

Estimated Enrollment: 60

Study Start Date: November 2012

Estimated Study Completion Date: September 2016

Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
 

Arms:

Active Comparator: pure galactose
5 grams of galactose, three times a day with the main meals, duration: 4 weeks

Placebo Comparator: pure palatinose
5 grams of palatinose, three times a day with the main meals, duration: 4 weeks

Placebo Comparator: soluble non-fermentable fibers
5 grams of soluble non-fermentable fibers, three times a day with the main meals, duration: 4 weeks

Active Comparator: non-soluble non-fermentable fibers
5 grams of non-soluble non-fermentable fibers, three times a day with each main meal, duration: 4 weeks