RCT Examining Effects of Probiotics in T2DM Individuals

NCT ID: NCT01752803

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-07-31

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.

Conditions

Type 2 Diabetes Mellitus; Obesity; Hypertension; Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

probiotic

subjects in this arm will receive probiotic supplementation for 12 weeks.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

mix probiotic

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

placebo

Interventions

Probiotic

mix probiotic

Intervention Type: DIETARY_SUPPLEMENT

Placebo

placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

mix probiotic supplementation

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Somayyeh Firouzi, Master

Role: PRINCIPAL_INVESTIGATOR

Nutrition and Dietetic department, University Putra Malaysia

Locations

Universiti Kebangsaan Malaysia Medical Center

Kuala Lumpur, WP, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Somayyeh Firouzi, master

Role: CONTACT

firouzi.som@gmail.com

0060-172118565

References

Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.

Reference Type: DERIVED

PMID: 37870148 (View on PubMed)

Firouzi S, Mohd-Yusof BN, Majid HA, Ismail A, Kamaruddin NA. Effect of microbial cell preparation on renal profile and liver function among type 2 diabetics: a randomized controlled trial. BMC Complement Altern Med. 2015 Dec 12;15:433. doi: 10.1186/s12906-015-0952-5.

Reference Type: DERIVED

PMID: 26654906 (View on PubMed)

Other Identifiers

Universiti Putra Malaysia

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

04-02-12-1815RU

Identifier Type: -

Identifier Source: org_study_id