- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01792986
The Fasting II Study
10. februar 2017 opdateret af: Intermountain Health Care, Inc.
Preparatory Study to Determine Which Risk Markers May be Reduced by Fasting and Should be Evaluated in a Future Randomized Trial
This study will determine whether an intensive fasting protocol alters hemoglobin A1c measurements or other markers of metabolic and cardiovascular risk by performing a 5-week clinical trial of fasting among 12 pre-diabetic individuals or diabetics whose disease is controlled by diet.
Participants will undergo a 5-week intervention of once-per-week 24-hour water-only fasting, including at baseline and at the end of the week for each week of the study (a total of 6 24-hour fasts).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Utah
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Murray, Utah, Forenede Stater, 84107
- Intermountain Medical Center
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Salt Lake City, Utah, Forenede Stater, 84107
- Intermountain Medical Center
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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
30 år til 69 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or non-pregnant female, ≥30 and <70 years of age.
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
Prior evidence of pre-diabetic state, with one of the following:
- Pre-diabetic with a measured hemoglobin A1c (HbA1c) ≥6.0% or fasting glucose >100 mg/dL without a clinical diabetes diagnosis
- Clinically-diagnosed type II diabetic with HbA1c ≥6.0% or fasting glucose ≥110 mg/dL and whose disease is controlled by diet alone.
Evidence of metabolic syndrome by having at least 3 of the following 5 criteria:
- Fasting glucose level >100 mg/dL.
- Blood pressure ≥135 mmHg systolic or ≥85 mmHg diastolic, or use of an antihypertensive medication.
- High-density lipoprotein cholesterol <40 mg/dL in males or <50 mg/dL in females.
- Triglycerides ≥150 mg/dL or use of a cholesterol-lowering medication.
- Waist circumference >40 inches (102 cm) for males or >35 inches (88 cm) for females (or body mass index >25 kg/m2).
Exclusion Criteria:
- Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Principal Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- Diabetics taking any of the following anti-diabetic medications: insulin, metformin, thiazolidinediones, sulfonylureas, alpha-glucosidase inhibitors, meglitinides, or incretins.
- Prior experience with fasting more than once per month (for 20 hours or more), on average during the last year.
- Very low body mass index (BMI) (<18.5 kg/m2) or high BMI (>40 kg/m2).
- Individuals who are nutritionally compromised, as assessed by the Principal Investigator.
- Any immunodeficiency or prior solid organ transplantation or renal disease.
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
- Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: water-only 24-hour fasting once per week for 6 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week.
Tidsramme: 6 weeks
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6 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Difference in Weight Between Baseline and the End of the Sixth Week
Tidsramme: 6 weeks
|
6 weeks
|
Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week.
Tidsramme: 6 weeks
|
6 weeks
|
Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week.
Tidsramme: 6 weeks
|
6 weeks
|
Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week.
Tidsramme: 6 weeks
|
6 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Benjamin D Horne, PhD, MPH, Intermountain Health Care, Inc.
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
1. februar 2013
Primær færdiggørelse (Faktiske)
1. juni 2013
Studieafslutning (Faktiske)
1. juni 2013
Datoer for studieregistrering
Først indsendt
12. februar 2013
Først indsendt, der opfyldte QC-kriterier
13. februar 2013
Først opslået (Skøn)
15. februar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. februar 2017
Sidst verificeret
1. juli 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1024469
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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