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Diet and Exercise Intervention in Type 2 Diabetes (LID)

13. april 2022 oppdatert av: Washington University School of Medicine
The purpose of this study is to determine the effect of a worksite-based intensive lifestyle therapy intervention (weight loss with exercise training) on blood sugar control in people with obesity and type 2 diabetics.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The purpose of this study is to conduct a randomized, controlled trial in people with obesity and type 2 diabetes to determine the therapeutic effects of intensive lifestyle therapy conducted at the worksite compared to standard care on: i) the major factors involved in the pathogenesis of type 2 diabetes (insulin sensitivity, β-cell function and the metabolic response to glucose ingestion), ii) body composition; iii) physical function (cardiorespiratory fitness and muscle strength); iv) and the potential cellular mechanisms that can affect insulin action in muscle and adipose tissue (fat).

Studietype

Intervensjonell

Registrering (Faktiske)

18

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
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine

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

25 år til 68 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 25-68 yrs old
  2. BMI 27.0-50.0 kg/m²
  3. Diagnosis of type 2 diabetes based on HbA1C>6.5% or results of an oral glucose tolerance test or current use of anti-diabetic medications
  4. HbA1C ≤9.5 %.
  5. Work at Washington University in St. Louis, Barnes Jewish Hospital, St. Louis Children's Hospital, Shriners, St. Louis College of Pharmacy, Central Institute for the Deaf, Rehabilitation Institute of St. Louis, and/or any institutions affiliated with these.

Exclusion Criteria:

  1. Any change in diabetes medication in previous 3 months
  2. Treated with >0.5 units of insulin/kg body weight per day
  3. Unstable weight (>2% change during the last 2 months before entering the study)
  4. History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or New York Heart Association class III heart failure (patients with marked limitation of activity and who are comfortable only at rest) or IV heart failure (patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity).
  5. Evidence of serious cardiac abnormalities during exercise stress testing that increase cardiac risk of initiating an exercise program.
  6. Creatinine >1.5 mg/dL
  7. Microalbuminuria; spot urine albumin:creatinine ratio >50 (50 μg albumin/mg creatinine)
  8. Coagulation disorders
  9. Anemia (Hemoglobin <10.0 g/dL)
  10. Liver enzymes (ALT and AST) ≥3 times the upper limit of normal
  11. Uncontrolled proliferative diabetic retinopathy
  12. Severe peripheral neuropathy diagnosed by monofilament testing
  13. Severe organ dysfunction
  14. Pregnant or breastfeeding
  15. Participating in regular exercise (>1 h of structured exercise/week)
  16. Joint replacement within the last year
  17. Smokes tobacco
  18. Severe lactose intolerance
  19. Take any medication that might interfere with interpretation of the metabolic studies
  20. Unable or unwilling to follow the study protocol or for any reason the research team believes the volunteer is not an appropriate candidate for this study, including non-compliance with screening appointments or previous medical visits.

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
Annen: Standard Care
Participants randomized to this arm will receive dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines.
Atferdsmessig: Standard Care
After receiving dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines participants will meet approximately every month for about 7 months with a study team member to record body weight, review diet and physical activity behaviors, and document medication use. Participants will continue their routine medical management, including regular clinic visits with their personal physician and/or diabetes educator during their participation in this study. Any changes medications will made by the participants' personal physician(s).
Eksperimentell: Intensive Lifestyle intervention
Participants randomized to this arm will be participate in weekly dietary and behavioral education session in addition to four 60-min supervised exercise training sessions per week for 8 months. All dietary and- behavioral education and exercise training sessions will be conducted at the worksite.
Atferdsmessig: Intensive Lifestyle Intervention
Participants will be instructed to consume ~500 kcal/day less than their calculated estimated total daily energy requirements. The supervised exercise program will include both endurance and resistance exercise training sessions. The doses of diabetes medications will be adjusted by study physicians every 1-2 weeks, as needed to avoid hypoglycemia.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Skeletal muscle insulin sensitivity
Tidsramme: 7-8 months
Skeletal muscle insulin sensitivity will be calculated as the glucose disposal rate per kg fat-free mass divided by plasma insulin during a hyperinsulinemic-euglycemic clamp procedure.
7-8 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Liver insulin sensitivity
Tidsramme: 7-8 months
Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index.
7-8 months
Adipose tissue insulin sensitivity
Tidsramme: 7-8 months
Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index.
7-8 months
β-cell function
Tidsramme: 7-8 months
β-cell function will be assessed from a modified oral glucose tolerance test
7-8 months
Insulin clearance
Tidsramme: 7-8 months
Insulin clearance will be assessed from a modified oral glucose tolerance test
7-8 months
Diabetes remission
Tidsramme: 7-8 months
Remission of type 2 diabetes will be defined as HbA1c <6.0% without the use of diabetes medications use of diabetes medications.
7-8 months
Cardiorespiratory fitness
Tidsramme: 7-8 months
Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion.
7-8 months
Muscle strength
Tidsramme: 7-8 months
Muscle strength will be assessed as the total maximal weight lifted during the 1 repetition maximum tests for leg press, knee flexion, seated row, and chest press exercises.
7-8 months
Whole-body fat mass
Tidsramme: 7-8 months
Total body fat mass will be assessed by dual-energy X-ray absorptiometry.
7-8 months
Whole-body fat-free mass
Tidsramme: 7-8 months
Fat-free mass will be assessed by dual-energy X-ray absorptiometry.
7-8 months
Appendicular lean mass
Tidsramme: 7-8 months
Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry.
7-8 months
Intra-abdominal adipose tissue volume
Tidsramme: 7-8 months
Intra-abdominal adipose tissue volume will be determined by using magnetic resonance imaging.
7-8 months
Intrahepatic triglyceride content
Tidsramme: 7-8 months
Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy.
7-8 months
Plasma adipokine concentrations
Tidsramme: 7-8 months
Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory.
7-8 months
Transcriptome in muscle and adipose tissue
Tidsramme: 7-8 months
The transcriptome (all RNA that are responsible for making proteins from DNA templates) will be evaluated by using RNA sequencing techniques.
7-8 months
Skeletal muscle mitochondrial metabolites
Tidsramme: 7-8 months
The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry.
7-8 months

Samarbeidspartnere og etterforskere

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

Sponsor

Washington University School of Medicine

Samarbeidspartnere

National Dairy Council
American Egg Board

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

1. oktober 2013

Primær fullføring (Faktiske)

1. juli 2016

Studiet fullført (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først innsendt

14. oktober 2013

Først innsendt som oppfylte QC-kriteriene

30. oktober 2013

Først lagt ut (Anslag)

6. november 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 201302095

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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