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Study of the Food Order Behavioral Intervention in Prediabetes

1. februar 2022 oppdatert av: Weill Medical College of Cornell University

A Randomized Controlled Pilot Study of the Food Order Behavioral Intervention in Prediabetes

Investigators have previously shown that eating carbohydrates after protein or vegetables resulted in reduced glucose and insulin excursions over 180 min in patients with T2DM and in individuals with prediabetes as well. This is an open label, randomized controlled pilot study to assess the efficacy of carbohydrate-last food order behavior in reducing the risk of progression to type 2 diabetes (T2DM).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Intensive diet and lifestyle modifications have been shown to reduce the risk of progression to T2DM in several randomized controlled trials. Key components of standard nutritional counseling include reducing calorie intake and glycemic load. Sequential nutrient ingestion is a novel strategy found to attenuate the glycemic effect of a meal. Investigators have previously shown that ingestion of carbohydrates after protein or vegetables results in reduced glucose and insulin excursions over 180 min in patients with T2DM. In addition, investigators also found that levels of the hunger hormone ghrelin were more suppressed at the end of 3 hours after a meal. Furthermore, investigators found that the glycemic effects of food order apply to individuals with prediabetes as well. This study follows previous research on nutrient order and seeks to determine the metabolic effects of this behavioral intervention in the real world. The study will include two randomized groups who are overweight or obese and are diagnosed with prediabetes. The control group will receive standard nutritional counseling at the start of the study and no instructions to change food order behavior. The intervention group will receive regularly scheduled food order counseling over a period of 16 weeks in addition to standard nutritional counseling at baseline. Anthropometric and metabolic parameters, including insulin sensitivity, will be assessed at baseline and at 16 weeks. The primary aim of this study is to determine the proportion of subjects who achieve 15% or greater improvement in 2 hour glucose on OGTT at 16 weeks. If shown to be effective, this data will inform the design of larger study focused on diabetes prevention.

Studietype

Intervensjonell

Registrering (Faktiske)

79

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • New York, New York, Forente stater, 10065
        • Comprehensive Weight Control Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Male and female subjects who are 21 years of age or older
  • BMI 25-40 kg/m2
  • Pre-diabetes defined by an HbA1c of 5.7-6.4%
  • Weight stable (< 5% body weight change over preceding 6 months)
  • Provide valid informed consent

Exclusion Criteria:

  • Previous diagnosis of T2DM or Hb1A1c greater than or equal to 6.5% or fasting glucose > 125mg/dl on screening or 2 hour glucose greater than or equal to 200 mg/dl on OGTT
  • Patients who are on any oral/ injectable medications used to treat diabetes including metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 analogs, SGLT2 inhibitors, glitazones and insulin
  • Patients on over the counter or approved weight loss medications
  • Pregnant or lactating females
  • Previous bariatric surgery
  • Psychotropic and/or other medications known to significantly impact weight unless on stable dose for 6 months
  • eGFR < 45ml/min
  • Significant hepatic, cardiac, gastrointestinal, neurologic or other medical illness that would preclude participation in the study
  • Untreated hypothyroidism or other endocrine disorders
  • Non-English speaking patients
  • Any patient deemed unsuitable in the investigator's opinion

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Food order behavioral intervention plus standard care
Subjects will receive standard nutrition counseling and additional carbohydrate-last food order behavioral counseling.
Atferdsmessig: Food order behavioral intervention plus standard care
Subjects in the Food order behavioral intervention plus standard care will receive standard counseling by a registered dietitian and additional carbohydrate last food order behavioral counseling by a member of the research team at baseline and Weeks 4, 8 and 12.
Annen: Standard care
Subjects will receive standard nutrition counseling.
Atferdsmessig: Standard Care
Subjects will receive standard counseling by a registered dietitian at the baseline visit. Standard counseling will be similarly reinforced at weeks 4, 8 and 12.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants achieving a normal 2-hour glucose (less than 140mg/dl) and/ or greater than or equal to 15% improvement in 2-hour glucose
Tidsramme: 16 weeks
Effect of food order counseling added to standard care on glucose tolerance in individuals with overweight/obesity and prediabetes as measured by the proportion of participants achieving a normal 2-hour glucose (less than 140mg/dl) and/ or greater than or equal to 15% improvement in 2-hour glucose
16 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Weill Medical College of Cornell University

Samarbeidspartnere

Louis and Rachel Rudin Foundation

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. februar 2019

Primær fullføring (Faktiske)

21. januar 2022

Studiet fullført (Faktiske)

21. januar 2022

Datoer for studieregistrering

Først innsendt

28. mars 2019

Først innsendt som oppfylte QC-kriteriene

28. mars 2019

Først lagt ut (Faktiske)

29. mars 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. februar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. februar 2022

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1807019463

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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