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

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 Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Dietary supplement (4 arms, 2 active, 2 placebo)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Charité-Klinikum Benjamin Franklin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pure galactose; 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)
Placebo Comparator: pure palatinose; 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)
Placebo Comparator: soluble non-fermentable fibers; 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)
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	Dietary supplement: Dietary supplement (4 arms, 2 active, 2 placebo)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition
• Collaborators: German Center for Diabetes Research; Firma Rettenmeier & Söhne (Company)
• Investigators: Principal Investigator: Andreas F.H. Pfeiffer, Prof. Dr. med., German Institute for Human Nutrition

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 25, 2013

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: nutrition; type 2 diabetes; fibers
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DiNA-S DiNA-F