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

NCT01776099 | Unknown

• 1 other identifier: DiNA-S DiNA-F
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; nutrition; fibers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

pure galactose

ACTIVE COMPARATOR

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)

pure palatinose

PLACEBO COMPARATOR

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)

soluble non-fermentable fibers

PLACEBO COMPARATOR

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)

non-soluble non-fermentable fibers

ACTIVE COMPARATOR

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)

Interventions

Dietary supplement (4 arms, 2 active, 2 placebo) DIETARY_SUPPLEMENT

non-soluble non-fermentable fibers; pure galactose; pure palatinose; soluble non-fermentable fibers

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes, insulin-dependent
• high insulin resistance

You may not qualify if:

• 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...)

Sponsors & Collaborators

• German Institute of Human Nutrition: lead
• Firma Rettenmeier & Söhne (Company): collaborator
• German Center for Diabetes Research: collaborator

Study Sites (1)

Charité-Klinikum Benjamin Franklin

Berlin, 12203, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Andreas F.H. Pfeiffer, Prof. Dr. med.

  German Institute for Human Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department for Clinical Nutrition

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 25, 2013
• Study Start: November 1, 2012
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 24, 2020

Record last verified: 2020-06

Locations

DE (1)