Effects of a Clinical Dietary Intervention During Inpatient Treatment (FASTA)
10. maj 2021 opdateret af: Andreas Michalsen, Charite University, Berlin, Germany
Effects of a Clinical Dietary Intervention During Inpatient Treatment (Modified Fasting in Metabolic Syndrome, Osteoarthritis of the Hip or Knee, Rheumatoid Arthritis and Fibromyalgia)
The purpose of the study is a scientific and prospective documentation of the clinical effects of an inpatient treatment at the Immanuel Hospital of Berlin, in the department for complementary and integrative medicine, with the use of a modified fasting regime.
A pre- and post- as well as group comparisons are planned.
Patients that are admitted to the inpatient department for metabolic syndrome, osteoarthritis of the hip or knee, rheumatoid arthritis and fibromyalgia will be enrolled in the study.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Intervention / Behandling
Detaljeret beskrivelse
At the beginning, during and at the end of the treatment at the inpatient department routine blood parameters, anthropometric parameters and certain scores and parameters specific to the different conditions will be measured.
Questionnaires will be filled out by patients before and after the treatment as well as 3, 6 and 12 months after leaving the inpatient department.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
500
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Berlin
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Berlin-Wannsee, Berlin, Tyskland, 14109
- Immanuel Hospital
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Regular hospitalised patients
Beskrivelse
Inclusion Criteria:
- The patient is consents to participating in the trial during the first 24h of his or her stay in the inpatient naturopathic department of the Immanuel Hospital.
- Written informed consent is given
- The referral diagnosis is one of the following: diabetes mellitus type 2/metabolic syndrome, osteoarthritis of the hip, osteoarthritis of the knee, rheumatoid arthritis, fibromyalgia.
Exclusion Criteria:
- Language barries to understanding the instructions of the study personnel
- Dementia or other strong cognitive impairment
- Pregnant or lactating women
- Taking part in another study at the same time
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fibromyalgia Impact Questionnaire (FIQ)
Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
Questionnaire; The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person.
Each of the 10 items has a maximum possible score of 10.
Thus the maximum possible score is 100.
The average FM patient scores about 50, severely afflicted patients are usually 70 plus.
|
Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
|
Disease Activity Score 28 (DAS 28)
Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
Questionnaire with Clinical Examination; Change from Baseline in the DAS-28, range from 2.0 to 10.0 while higher values meaning a higher disease activity and below of 2.6 meaning remission
|
Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
|
Health Assessment Questionnaire (HAQ)
Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
Questionnaire; Change from Baseline in the HAQ, range from 0 to 3 while higher values meaning a higher grade of disability
|
Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
Questionnaire consisting of 24 items divided into 3 subscales: Pain (5items), Stiffness (2 items), Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher values meaning a higher grade of disability. |
Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
|
Summary of Diabetes Self Care Activities Measure (SDSCA)
Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
Questionnaire; 11 items with each item scored on a scale of 0-7.
|
Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain on Visual Analogue Scale (VAS)
Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
Questionnaire
|
Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
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Hospital Anxiety and Depression Scale (HADS)
Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
Questionnaire; HADS: Assessing full scale, range 0-42, lower score meaning a better outcome
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Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
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Perceived Stress Scale (PSS)
Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
Questionnaire; Change from Baseline in the PSS, range from 0 to 4 in each item.
Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.
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Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
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Quality of Life (WHO-5)
Tidsramme: Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
Questionnaire; Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being
|
Change Baseline, 2 weeks, 3 months, 6 months, 12 months
|
|
Body-Mass-Index (BMI)
Tidsramme: Change Baseline, 2 weeks
|
Anthropometry
|
Change Baseline, 2 weeks
|
|
Blood pressure
Tidsramme: Change Baseline, 2 weeks
|
Measuring systolic and diastolic blood pressure in mmHg
|
Change Baseline, 2 weeks
|
|
24h-Blood pressure
Tidsramme: Change Baseline, 2 weeks
|
Measuring systolic and diastolic blood pressure with Device "Mobil-O-Graph"
|
Change Baseline, 2 weeks
|
|
Blood count
Tidsramme: Change Baseline, 2 weeks
|
Laboratory test
|
Change Baseline, 2 weeks
|
|
Glomerular filtration rate (GFR)
Tidsramme: Change Baseline, 2 weeks
|
Laboratory test
|
Change Baseline, 2 weeks
|
|
Blood lipids
Tidsramme: Change Baseline, 2 weeks
|
triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L), fasting glucose (mmol/L)
|
Change Baseline, 2 weeks
|
|
CRP
Tidsramme: Change Baseline, 2 weeks
|
CRP in milligram per liter (mg/L)
|
Change Baseline, 2 weeks
|
|
Liver enzymes (GOT, GPT)
Tidsramme: Change Baseline, 2 weeks
|
Hepatic transaminases (GPT, GOT in U/L)
|
Change Baseline, 2 weeks
|
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Stepcounter
Tidsramme: Change Baseline, 2 weeks
|
With Device "Everion"
|
Change Baseline, 2 weeks
|
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Heart Rate Variability
Tidsramme: Change Baseline, 2 weeks
|
With Device "Faros 180"
|
Change Baseline, 2 weeks
|
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Heart Rate
Tidsramme: Change Baseline, 2 weeks
|
With Device "Everion"
|
Change Baseline, 2 weeks
|
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Blood Oxygenation
Tidsramme: Change Baseline, 2 weeks
|
With Device "Everion"
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Change Baseline, 2 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Andreas Michalsen, Prof. Dr., study principal investigator
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2018
Primær færdiggørelse (Forventet)
1. marts 2022
Studieafslutning (Forventet)
1. marts 2022
Datoer for studieregistrering
Først indsendt
20. december 2018
Først indsendt, der opfyldte QC-kriterier
20. december 2018
Først opslået (Faktiske)
24. december 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. maj 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. maj 2021
Sidst verificeret
1. maj 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i nervesystemet
- Sygdomme i immunsystemet
- Autoimmune sygdomme
- Sygdom
- Ledsygdomme
- Muskuloskeletale sygdomme
- Reumatiske sygdomme
- Bindevævssygdomme
- Muskelsygdomme
- Neuromuskulære sygdomme
- Insulin resistens
- Hyperinsulinisme
- Syndrom
- Gigt
- Gigt, reumatoid
- Slidgigt
- Slidgigt, knæ
- Metabolisk syndrom
- Fibromyalgi
- Myofasciale smertesyndromer
- Slidgigt, Hofte
Andre undersøgelses-id-numre
- FASTA
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