RCT Examining Effects of Probiotics in T2DM Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01752803
Recruitment Status : Unknown
Verified September 2014 by Universiti Kebangsaan Malaysia Medical Centre.
Recruitment status was:  Recruiting
First Posted : December 19, 2012
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):
Universiti Kebangsaan Malaysia Medical Centre

Brief Summary:

Background: The connection between gut health and diabetes status is increasingly recognized. Gut microbiota composition in diabetic differs from non-diabetic individuals. Interestingly, the level of glucose tolerance was associated with specific microbiota that was rarely found in healthy individuals. Probiotics is one of the functional foods believed to mediate their health promoting activities through modulating the composition of the gut health. Ingestion of probiotics has been shown not only to influence gut microbiota composition but also the secretion of the gut hormones and insulin resistance in animal models with limited trials in human. Supplementation with probiotic has also been shown not only affect glucose homeostasis, but improved other diabetes related comorbidities such as obesity, hypertension, and hyperlipidemia.

Objectives and hypotheses: To address this research gap, this Randomized Controlled Trial (RCT) is proposed to determine the efficacy of probiotic supplementations as adjuvant therapy to improve glucose homeostasis through modulating gut microbiota composition and gut hormones secretion in individuals with type 2 diabetes. We hypothesized that the probiotic supplementations will improve blood glucose control as well as other diabetes related co-morbidities in individuals with type 2 diabetes.

Methodology: This is a double blind randomized parallel group control trial with 3 months probiotic supplementation or placebo. After screening the eligible subjects will be selected. Then, after consent taking, subjects will be randomly assigned to either receive probiotic or supplement for 3 months. Measurements of blood parameters including glycemic control related parameters, lipid profile, renal profile, and liver function tests as well as three day diet recall, and anthropometry measurements will take place at baseline, after 6 weeks and after 12 months.

Expected Outcomes: Probiotic supplementation as an adjuvant therapy would improve glucose homeostasis and gut health as compared to the placebo and eventually will beneficially affect other diabetes related conditions. This study would provide avenue to identify the possibility of probiotic supplementations as an adjuvant therapy in the management of type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Obesity Hypertension Hyperlipidemia Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized Placebo-controlled Parallel Group Study of Probiotics as an Adjuvant Therapy for Individuals With Type 2 Diabetes Mellitus
Study Start Date : December 2012
Actual Primary Completion Date : July 2013
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: probiotic
subjects in this arm will receive probiotic supplementation for 12 weeks.
Dietary Supplement: Probiotic
mix probiotic
Other Name: mix probiotic supplementation

Placebo Comparator: placebo
subjects in this arm will receive placebo in identical sachets similar to probiotics which only differs in the codes mentioned on the label of sachets.
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. Hb A1c [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. inflammatory markers [ Time Frame: 3 months ]

Other Outcome Measures:
  1. Lipoproteins [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Established type 2 diabetes with at least 6 months diagnosis
  2. Age between 30 and 65 years
  3. Hb A1c of less than 10% and fasting blood glucose less than 15mmol/l
  4. BMI between 18.5-35 kg/ m2
  5. Have not on any probiotics for the last 2 months prior to the recruitment
  6. Ability to comply to the study protocol
  7. They are treated with stabilized dose of medications (either receiving Sulphonylurea or Biguanides or both)

Exclusion Criteria:

  1. Pregnancy and lactating (subjects will be excluded if they getting pregnant during course of study)
  2. Having advanced diabetes complications except for hypertension and hyperlipidemia
  3. Having acute or chronic illness (such as flu, cancer or arthritis rheumatoid) during the study recruitment which may affect carbohydrate metabolism
  4. Language barriers which cannot be overcome via available resources
  5. Currently being treated with any oral anti-diabetes agents other than Sulphonylurea or Biguanides or being treated with insulin
  6. Using any medication such as steroids or antibiotics which might affect viability of gut microorganism at recruitment and during intervention phase.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01752803

Contact: Somayyeh Firouzi, master 0060-172118565

Universiti Kebangsaan Malaysia Medical Center Recruiting
Kuala Lumpur, WP, Malaysia, 56000
Principal Investigator: Somayyeh Firouzi, Master         
Sponsors and Collaborators
Universiti Kebangsaan Malaysia Medical Centre
Principal Investigator: Somayyeh Firouzi, Master Nutrition and Dietetic department, University Putra Malaysia

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Universiti Kebangsaan Malaysia Medical Centre Identifier: NCT01752803     History of Changes
Other Study ID Numbers: 04-02-12-1815RU
Universiti Putra Malaysia ( Other Grant/Funding Number: Universiti Putra Malaysia )
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders