RBR-47232z Maltodextrin alter glycemia on Diabetics

Date of registration: 07/08/2013 ^(mm/dd/yyyy)
Last approval date : 07/08/2013 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1129-8637

• Public title:

  en

  Maltodextrin alter glycemia on Diabetics

  pt-br

  Maltodextrina altera glicemia no Diabetes

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 0051.0.300.000-09
    Issuing authority: SISNEP

Sponsors

• Primary sponsor: Universidade Estadual do Centro - Oeste
• Secondary sponsor:
  • Institution: Universidade Estadual do Centro - Oeste
• Supporting source:
  • Institution: Universidade Estadual do Centro - Oeste

Health conditions

• Health conditions:

  en

  Elderly, Diabetes Mellitus Type 2, glicemic control

  pt-br

  Idosos, Diabetes Mellitus Tipo 2, controle glicêmico

• General descriptors for health conditions:

  en

  C19 Endocrine system diseases

  pt-br

  C19 Doenças do sistema endócrino

  es

  C19 Enfermedades del sistema endocrino

• Specific descriptors:

Interventions

• Interventions:

  en

  The subjects of the study, six healthy volunteers aged between 40 and 60 years, diagnosed with Type 2 Diabetes Mellitus from medical records and health units in the of Engenheiro Gutierrez and Riozinho in Irati - PR. Acutely on the day of the experiment, the subjects received the supplement containing 100mg/kg (control) or 1g/kg 2g/kg maltodextrin dissolved in 450 ml of distilled water. After intake of the supplement, subjects remained seated (rest) for thirty minutes after the start of exercise. The subjects received all three supplements and did three tests on different days, at least 48 hours apart.

  pt-br

  Foram sujeitos do estudo, 6 indivíduos voluntários com idades compreendidas entre 40 e 60 anos, diagnosticados com Diabetes Mellitus Tipo 2 a partir de consulta médica e cadastro nos Postos de Saúde de Engenheiro Gutierrez e Riozinho em Irati – PR. De forma aguda, no dia do experimento, os sujeitos da pesquisa receberam o suplemento contendo 100mg/kg (controle), 1g/kg ou 2g/kg de maltodextrina, dissolvido em 450 ml de água destilada. Após a ingestão do suplemento, os indivíduos mantiveram-se sentados (repouso) durante trinta minutos para posterior início do exercício. Os indivíduos receberam as três suplementações e fizeram os três testes em dias diferentes, com no mínimo 48 horas de diferença.

• Descriptors:

  en

  SP6.051.227 Supplementary Feeding

  pt-br

  SP6.051.227 Suplementação Alimentar

  es

  SP6.051.227 Alimentación Suplementaria

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 04/09/2011 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  6	-	40 Y	60 Y

• Inclusion criteria:

  en

  Type 2 Diabetes Mellitus

  pt-br

  Diabetes Mellitus Tipo 2

• Exclusion criteria:

  en

  Physical Disability, Limiting Pathology, Age

  pt-br

  Deficiencia Física, Patologia Limitante, Idade

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Prevention	Single-group	3	Double-blind	Randomized-controlled	2

Outcomes

• Primary outcomes:

  en

  For inclusion of individuals to the interview was conducted a clinical interview where he was selected persons who had type 2 diabetes aged between 40 and 60 years, and if there were any limiting condition (eg Osteo-muscular Disease, Arthritis, Diseases cardiac, respiratory diseases) were excluded.

  pt-br

  Para inclusão dos indivíduos à pesquisa, foi realizado uma anamnese clínica aonde foi selecionado pessoas que tivessem Diabetes Tipo 2 com idades entre 40 e 60 anos, sendo que, se houvesse alguma patologia limitantes (p.ex. Doenças Osteo-musculares, Artrite, Doenças Cardíacas, Doenças Respiratórias) seriam excluídas do estudo.

• Secondary outcomes:

  en

  Before exercise or supplementation, was measured Blood Pressure (BP) and Heart Rate (HR), and if the PA was greater than 140 mm / Hg for systolic and 90 mm ??/ Hg diastolic, this individual was not requiring the physical test . The same occurred with blood glucose levels, where levels higher than 150 mg / dL were considered at risk for exercise. During the year, BP, HR, plasma glucose and Borg scale (level of effort) were measured respectively, and questioned if some guy was putting at risk, the test was interrupted physical.

  pt-br

  Antes do exercício ou suplementação, foi aferido a Pressão Arterial (PA) e a Frequência Cardíaca (FC), sendo que se a PA estivesse maior que 140 mm/Hg para sistólica e 90 mm/Hg para diastólica, esse individuo era dispensando do teste físico. O mesmo ocorreu com a glicemia, aonde níveis superiores à 150 mg/dL foram considerados de risco para o exercício. Durante o exercício, PA, FC, Glicemia e a escala de Borg (nível de esforço) foram medidas e questionadas respectivamente, se alguma estivesse colocando o sujeito em risco, era interrompido o teste de físico.

Contacts

• Public contact
  • Full name: Carlos Ricado Malfatti
  • • Address:
    • City: Itati / Brazil
    • Zip code: 84500-000
  • Phone: (42) 3421-3000
  • Email: crmalfatti@gmail.com
  • Affiliation: Universidade Estadual do Centro - Oeste
   
• Scientific contact
  • Full name: Carlos Ricado Malfatti
  • • Address: VEREADOR RUBEM SIQUEIRA RIBAS
    • City: Guarapuava / Brazil
    • Zip code: 85.015-080
  • Phone: (42) 3621-1000
  • Email: crmalfatti@gmail.com
  • Affiliation: Universidade Estadual do Centro - Oeste
  • Full name: Carlos Ricado Malfatti
  • • Address:
    • City: Itati / Brazil
    • Zip code: 84500-000
  • Phone: (42) 3421-3000
  • Email: crmalfatti@gmail.com
  • Affiliation: Universidade Estadual do Centro - Oeste
   
• Site contact
  • Full name: Carlos Ricado Malfatti
  • • Address:
    • City: Itati / Brazil
    • Zip code: 84500-000
  • Phone: (42) 3421-3000
  • Email: crmalfatti@gmail.com
  • Affiliation: Universidade Estadual do Centro - Oeste
   

Additional links:

• Download in ICTRP format