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Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk in Patients With Type 2 Diabetes

27. maj 2026 opdateret af: Joslin Diabetes Center

Effect of Consumption of Dairy Products on Glycemic Control, Body Weight and Cardiovascular Risk Factors in Patients With Type 2 Diabetes: A Randomized Controlled Clinical Study

This is a randomized prospective clinical study in patients with type 2 diabetes to evaluate the effect of dairy products with full or low fat on glycemic control and cardio-metabolic risk factors in comparison to a regular diet.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized, controlled clinical study in which 108 subjects with type 2 diabetes will be randomized into 3 different groups:

Full fat dairy group (Group A): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet

Low fat dairy group (Group B): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet

Control group (Group C): will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products

Subjects in Groups A and B will be educated about different dairy products' serving sizes and fat content. Subjects in all 3 groups will be asked to record their daily intake of dairy products in a dedicated log book. Subjects randomized to groups A and B will be asked to only use only dairy products with either the full fat or and low (≤1%) fat dairy (≤1% fat content) content respectively. Purchase of the dairy products will be the responsibility of study subjects for which a subsidy of $500 (about $20/week for 24 weeks) will be provided for each subject. All study participants will also be asked to record their food intake for 3 days before each study visit in a 3-day food log.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

112

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Joslin Diabetes Center

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Having type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication
  • A1C ≥7 %
  • Consuming <3 servings of dairy products per day
  • On stable dose of diabetes, blood pressure or cholesterol medications for 3 months
  • Body weight is within 10% of current weight over the last 6 months before starting the study

Exclusion Criteria:

  • Pregnancy or lactation
  • Lactose intolerance
  • Allergy to milk or any of its components
  • Use of orlistat
  • History of pancreatitis
  • History of gastric bypass surgery or sleeve gastrectomy
  • Active malignancy
  • History of recent cardiovascular event
  • Having a heart pacemaker
  • Enrollment in other studies that may affect study outcomes

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Full fat dairy group
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietitian and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
Andet: Full fat dairy
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
Eksperimentel: Low fat dairy group
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietitian and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
Andet: Low fat dairy
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
Andet: Control group
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
Andet: Control
Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in Hemoglobin A1C (A1C)
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in body weight
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in total cholesterol
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in high-density lipoprotein (HDL)
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in low-density lipoprotein (LDL)
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in triglycerides
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in fasting plasma glucose
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index after 24 weeks compared to baseline
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in body fat percentage
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in fat free mass
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Height in meters
Tidsramme: Baseline
Used in calculation of Body Mass Index
Baseline
Change in total body water
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in waist circumference
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in trunk fat percentage
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in visceral fat level
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in blood pressure
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks
Change in c-reactive protein level
Tidsramme: Baseline, 12 weeks and 24 weeks
Baseline, 12 weeks and 24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Joslin Diabetes Center

Efterforskere

  • Ledende efterforsker: Osama Hamdy, M.D., Ph.D., Joslin Diabetes Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. maj 2016

Primær færdiggørelse (Faktiske)

1. juli 2018

Studieafslutning (Faktiske)

1. august 2018

Datoer for studieregistrering

Først indsendt

4. maj 2016

Først indsendt, der opfyldte QC-kriterier

6. september 2016

Først opslået (Anslået)

12. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2016-04

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Type 2 diabetes

Kliniske forsøg med Full fat dairy

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Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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