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

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo)

• Registration Number: NCT01776099
• Lead Sponsor: German Institute of Human Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-25
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-24
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
soluble non-fermentable fibers	Dietary supplement (4 arms, 2 active, 2 placebo)	5 grams of soluble non-fermentable fibers, three times a day with the main meals, duration: 4 weeks
pure galactose	Dietary supplement (4 arms, 2 active, 2 placebo)	5 grams of galactose, three times a day with the main meals, duration: 4 weeks
pure palatinose	Dietary supplement (4 arms, 2 active, 2 placebo)	5 grams of palatinose, three times a day with the main meals, duration: 4 weeks
non-soluble non-fermentable fibers	Dietary supplement (4 arms, 2 active, 2 placebo)	5 grams of non-soluble non-fermentable fibers, three times a day with each main meal, duration: 4 weeks

Primary Outcome Measures

Name	Time	Method
metabolic improvement of type 2 diabetes	4 weeks	metabolic improvement of type 2 diabetes, as to be shown via hyperinsulinemic-euglycaemic clamp, mixed-meal test and daily demand of insulin units

Trial Locations

Locations (1)

Charité-Klinikum Benjamin Franklin; 🇩🇪 Berlin, Germany