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Diabetes Prevention Program in Schizophrenia [DPPS]

14 september 2005 bijgewerkt door: Hamilton Health Sciences Corporation

A Five Year, Prospective, Randomized, Blinded, Controlled Trial Comparing the Efficacy of a Modified Diabetes Prevention Protocol and the Standard Comprehensive Outpatient Care in Lowering the Incidence of New Onset Diabetes Among People Treated for Schizophrenia and Are at Risk to Develop Type II Diabetes Mellitus.

Diabetes is 2-5 times more common in schizophrenia and it is a preventable; but the current diabetes prevention guidelines are not suitable for implementation in the severely mentally ill population. The principles of diabetes prevention are essentially dietary regulation, increased physical activity and adjunctive use of oral anti-diabetic drugs (metformin). In a modified diabetes prevention protocol suitable for use in mentally ill population, we packaged the original guide lines with an adventure and recreation program based on principles of experiential learning, cognitive restructuring and behaviour modification. In this proposed study, we plan to evaluate the feasibility of adopting the new protocol, and examine its effectiveness in preventing diabetes.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Rationale:

  • From large international RCT studies, Type 2 Diabetes can be prevented / delayed for overweight, pre-diabetic individuals by making basic lifestyle changes (regular moderate exercise, healthy eating habits) and using metformin or other insulin resistance inhibitor.
  • Individuals with schizophrenia are in particular need of preventative intervention and conventional approaches do not match their needs.
  • Research has not examined how to facilitate lifestyle changes in the lives of individuals with schizophrenia.

We need to…

  • Develop and evaluate innovative diabetes prevention strategies tailored to meet the needs of individuals with schizophrenia.
  • Research how to make it work for pre-diabetic individuals being treated for schizophrenia.

The effectiveness of the novel intervention will be tested using a prospective, randomized, controlled clinical trial. A multi-factorial design enables a 2 x 2 analysis of the independent effects of three interventions - a tailored lifestyle modification program, metformin, and the standard conventional intervention. There is no anticipated interaction effect between metformin and lifestyle interventions. Clients currently treated for schizophrenia at a community outpatient clinic will be screened for diabetes, and those who fulfill the inclusion criteria, and give written consent, following a three week run-in period, will be randomized to one of four groups to receive either: the experimental intervention with placebo, the experimental intervention with metformin or the conventional intervention with placebo or conventional intervention with metformin.

Studietype

Ingrijpend

Inschrijving

200

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Lakshmi P Voruganti, MD
  • Telefoonnummer: 6355 905-522-1155
  • E-mail: vorugl@mcmaster.ca

Studie Contact Back-up

Studie Locaties

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Werving
        • McMaster University
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Lakshmi P Voruganti, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. People who are at least 18 years old, diagnosed as having schizophrenia, confirmed through a structured clinical interview (SCID-P) for DSM IV, treated with antipsychotic drugs at least for 2 years and deemed clinically stable. Clinical stability is operationally defined as absence of a relapse warranting hospitalization in the preceding six months.
  2. People who are deemed as "pre-diabetics" in accordance with the diagnostic criteria established by the American Diabetic Association (ADA, 2004) as following: impaired fasting glucose (IFG) indicating fasting plasma glucose ranging between 100-125 mg/dl or 5.6 - 6.9 mmol/l.; and impaired glucose tolerance (IGT) indicating 2-h post-load glucose ranging between 140-199 mg/dl or 7.8 - 11.0 mmol/l.
  3. People who have gained > 10% body weight since??? Or body mass index > 24 kg/m², except Asian decent at 22 kg/m² or greater??
  4. Competent to provide informed consent to voluntarily participate in the study.

Exclusion Criteria:

  1. People who meet the criteria for diabetes, (i.e., repeat fasting blood glucose (FBG) >7 mmol/l or, 2 hr. post-load glucose >11.1 mmol. as determined by a 2 hr. glucose tolerance test (GTT)).
  2. People with evidence of clinically significant liver disease, renal or gastrointestinal impairments, as suggested by clinical history and liver and kidney functions tests. Any impairment deemed clinically significant would be a relative contra-indication for the use of metformin.
  3. Women in the child bearing age, who are not willing to use contraceptive measures.
  4. People with other comorbid disorders such as clinically significant heart or lung disease that may prevent participation in various physical activities or disorders of glucose metabolism (e.g., Cushing's Syndrome, Acromegaly, and chronic pancreatitis).
  5. People with treatments that would interfere with participation or completion of the protocol (e.g., in shared care and planning to be discharged shortly from the clinic), or having a confounding effect on the measurement of the primary outcomes of the study (prescription weight loss drugs, lipid lowering agents?)
  6. People with weight loss >10% in past 6 months

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
1. Adherence/ability to run as designed /recruitment
2. Impact on modifiable diabetes risk factors
3. Impact on incidence of diabetes

Secundaire uitkomstmaten

Uitkomstmaat
1. Adherence Rates for Diet, Exercise, Meds
2. Changes in lifestyle, Changes in eating patterns, Changes in activity patterns
3. Sustained changes in eating & activity patterns

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hamilton Health Sciences Corporation

Medewerkers

The Lawson Foundation
Ontario Mental Health Foundation

Onderzoekers

  • Hoofdonderzoeker: Lakshmi P Voruganti, MD, McMaster University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2005

Studie voltooiing

1 januari 2009

Studieregistratiedata

Eerst ingediend

14 september 2005

Eerst ingediend dat voldeed aan de QC-criteria

14 september 2005

Eerst geplaatst (Schatting)

16 september 2005

Updates van studierecords

Laatste update geplaatst (Schatting)

16 september 2005

Laatste update ingediend die voldeed aan QC-criteria

14 september 2005

Laatst geverifieerd

1 juli 2005

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 04-2417

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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