Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes (DiNA-S DiNA-F)
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| ClinicalTrials.gov Identifier: NCT01776099 |
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Recruitment Status : Unknown
Verified June 2020 by Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition.
Recruitment status was: Active, not recruiting
First Posted : January 25, 2013
Last Update Posted : June 24, 2020
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Sponsor:
German Institute of Human Nutrition
Collaborators:
Firma Rettenmeier & Söhne (Company)
German Center for Diabetes Research
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes | Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes |
| Study Start Date : | November 2012 |
| Estimated Primary Completion Date : | October 2021 |
| Estimated Study Completion Date : | December 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
MedlinePlus related topics:
Dietary Fiber
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: pure galactose
5 grams of galactose, three times a day with the main meals, duration: 4 weeks
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Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo) |
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Placebo Comparator: pure palatinose
5 grams of palatinose, three times a day with the main meals, duration: 4 weeks
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Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo) |
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Placebo Comparator: soluble non-fermentable fibers
5 grams of soluble non-fermentable fibers, three times a day with the main meals, duration: 4 weeks
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Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo) |
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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
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Dietary Supplement: Dietary supplement (4 arms, 2 active, 2 placebo) |
Primary Outcome Measures :
- metabolic improvement of type 2 diabetes [ Time Frame: 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
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| Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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...)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776099
Locations
| Germany | |
| Charité-Klinikum Benjamin Franklin | |
| Berlin, Germany, 12203 | |
Sponsors and Collaborators
German Institute of Human Nutrition
Firma Rettenmeier & Söhne (Company)
German Center for Diabetes Research
Investigators
| Principal Investigator: | Andreas F.H. Pfeiffer, Prof. Dr. med. | German Institute for Human Nutrition |
| Responsible Party: | Prof. Dr. med. Andreas F. H. Pfeiffer, Director of the Department for Clinical Nutrition, German Institute of Human Nutrition |
| ClinicalTrials.gov Identifier: | NCT01776099 |
| Other Study ID Numbers: |
DiNA-S DiNA-F |
| First Posted: | January 25, 2013 Key Record Dates |
| Last Update Posted: | June 24, 2020 |
| Last Verified: | June 2020 |
Keywords provided by Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition:
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type 2 diabetes nutrition fibers |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |