- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02459496
Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus (DiNA-D)
Dietary Strategies to Improve Metabolism and Body Weight in Type 2 Diabetes
Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.
The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.
The researchers therefore investigate dietary strategies such as low-carb diets and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.
An intensive intervention of 3 weeks is followed by an 11-month maintenance phase to consolidate metabolic improvements.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Stefan Kabisch, Dr. med.
- Telefonnummer: 429 030 450 514
- E-post: stefan.kabisch@dife.de
Studer Kontakt Backup
- Navn: June Inderthal
- Telefonnummer: 033 200 88 2771
- E-post: june.inderthal@dife.de
Studiesteder
-
-
-
Berlin, Tyskland, 12203
- Rekruttering
- German Institute for Human Nutrition, Department for Clinical Nutrition
-
Ta kontakt med:
- Stefan Kabisch, Dr. med.
- Telefonnummer: 429 030 450 514
- E-post: stefan.kabisch@charite.de
-
Ta kontakt med:
- Ulrike Kaiser, M.sc.
- Telefonnummer: 428 030 450 514
- E-post: ulrike.kaiser@charite.de
-
Underetterforsker:
- Stefan Kabisch, Dr. med.
-
Underetterforsker:
- Ulrike Kaiser, M.sc.
-
-
Brandenburg
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Bergholz-Rehbrücke, Brandenburg, Tyskland, 14458
- Har ikke rekruttert ennå
- German Institut for Human Nutrition; Department for Clinical Nutrition
-
Ta kontakt med:
- Margrit Kemper, Dr. med.
- Telefonnummer: 033200 88 2775
- E-post: margrit.kemper@dife.de
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Ta kontakt med:
- Silke Hornemann
- Telefonnummer: 033200 88 2779
- E-post: silke.hornemann@dife.de
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Underetterforsker:
- Margrit Kemper, Dr. med.
-
Underetterforsker:
- Silke Hornemann
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Underetterforsker:
- Christiana Gerbracht, Dr.
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- male and female subjects
- 18-79 years old
- type 2 diabetes
Exclusion Criteria:
- renal insufficiency
- anaemia
- immunosuppression
- previous symptomatic cancer diagnosis
- acute cardiovascular disease (stroke, coronary syndrome)
- pregnancy and lactation
- severe psychiatric disorders
- corticoid or other immunosuppressive therapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: low-carb diet, followed by conventional DGE diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory low-carb ketogenic diet (VLCKD, below 40 g carbs per day), followed by an isocaloric or moderate hypocaloric low-carb diet (below 40 kcal% carbs per day)
|
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
|
Aktiv komparator: very-low calory diet, followed by conventional diet
subjects receive dietary consulting for a first phase of 3 weeks, being represented by a very-low calory diet (VLCD; MODIFAST substitute, approx.
1200 kcal/day), followed by a conventional isocaloric or moderate hypocaloric diet under DGE guidelines
|
first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
change in insulin secretion (glucagon stimulation test)
Tidsramme: 3 weeks, 1 year
|
change in insulin secretion (glucagon stimulation test)
|
3 weeks, 1 year
|
change in hepatic fat content (MR-S)
Tidsramme: 3 weeks, 1 year
|
change in hepatic fat content (MR-S)
|
3 weeks, 1 year
|
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
Tidsramme: 3 weeks, 1 year
|
change in insulin secretion in the mixed-meal tolerance test (MMTT) - combined parameter
|
3 weeks, 1 year
|
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
Tidsramme: 3 weeks, 1 year
|
change in insulin sensitivity in the mixed-meal tolerance test (MMTT) - combined parameter
|
3 weeks, 1 year
|
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
Tidsramme: 3 weeks, 1 year
|
change in blood glucose profile in the mixed-meal tolerance test (MMTT) - combined parameter
|
3 weeks, 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level - IL-1; IL1beta, IL-6)
Tidsramme: 3 weeks, 1 year
|
inflammatory reaction in subcutaneous adipose tissue (SCAT analysis on protein and RNA level)
|
3 weeks, 1 year
|
change in parameters of peripheral - vibration threshold, thermal sensitivity and pain thresholds
Tidsramme: 3 weeks, 1 year
|
peripheral neuropathy
|
3 weeks, 1 year
|
change in parameters of autonomic neuropathy - measures of cardio-autonomic neuropathy (SANN, MSDD)
Tidsramme: 3 weeks, 1 year
|
autonomic neuropathy
|
3 weeks, 1 year
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Andreas F.H. Pfeiffer, Prof. Dr. med., German Institute of Human Nutrition
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DiNA-D
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