Type 2 Diabetes MellitusNCT01752803
RCT Examining Effects of Probiotics in T2DM Individuals
A study testing Probiotic in people with Type 2 Diabetes Mellitus and Obesity, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity, Hypertension
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- Dec 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established type 2 diabetes with at least 6 months diagnosis
- Age between 30 and 65 years
- Hb A1c of less than 10% and fasting blood glucose less than 15mmol/l
- BMI between 18.5-35 kg/ m2
- Have not on any probiotics for the last 2 months prior to the recruitment
- Ability to comply to the study protocol
- They are treated with stabilized dose of medications (either receiving Sulphonylurea or Biguanides or both)
Who cannot join
- Pregnancy and lactating (subjects will be excluded if they getting pregnant during course of study)
- Having advanced diabetes complications except for hypertension and hyperlipidemia
- Having acute or chronic illness (such as flu, cancer or arthritis rheumatoid) during the study recruitment which may affect carbohydrate metabolism
- Language barriers which cannot be overcome via available resources
- Currently being treated with any oral anti-diabetes agents other than Sulphonylurea or Biguanides or being treated with insulin
- Using any medication such as steroids or antibiotics which might affect viability of gut microorganism at recruitment and during intervention phase.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Kebangsaan Malaysia Medical Center
Kuala Lumpur, WP, 56000
Somayyeh Firouzi, Master
About this study
Official title: A Double-blind, Randomized Placebo-controlled Parallel Group Study of Probiotics as an Adjuvant Therapy for Individuals With Type 2 Diabetes Mellitus
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.
Read more
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
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called mix probiotic supplementation
mix probiotic
PlaceboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| probiotic | Experimental | subjects in this arm will receive probiotic supplementation for 12 weeks. Receives: Dietary Supplement: Probiotic |
| placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb A1c
Measured: 3 months
Secondary outcomes (1)
inflammatory markers
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Somayyeh Firouzi, Master, Principal investigator, Nutrition and Dietetic department, University Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752803
- Sponsor's protocol ID
- 04-02-12-1815RU
- Other IDs
- Universiti Putra Malaysia
- Status last verified
- Sep 2014
- First submitted
- 16 Dec 2012
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37870148Firouzi 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.
PubMed 26654906
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Placebo-controlled Parallel Group Study of Probiotics as an Adjuvant Therapy for Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01752803
- Acronym / sponsor ID
- 04-02-12-1815RU
- Conditions
- Type 2 Diabetes Mellitus, Obesity, Hypertension, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2015 (estimated)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic | Experimental | Dietary Supplement: Probioticsubjects in this arm will receive probiotic supplementation for 12 weeks. |
| placebo | Placebo comparator | Dietary Supplement: Placebosubjects in this arm will receive placebo in identical sachets similar to probiotics which only differs in the codes mentioned on the label of sachets. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Established type 2 diabetes with at least 6 months diagnosis
- Age between 30 and 65 years
- Hb A1c of less than 10% and fasting blood glucose less than 15mmol/l
- BMI between 18.5-35 kg/ m2
- Have not on any probiotics for the last 2 months prior to the recruitment
Key exclusion criteria (6 listed)
- Pregnancy and lactating (subjects will be excluded if they getting pregnant during course of study)
- Having advanced diabetes complications except for hypertension and hyperlipidemia
- Having acute or chronic illness (such as flu, cancer or arthritis rheumatoid) during the study recruitment which may affect carbohydrate metabolism
- Language barriers which cannot be overcome via available resources
- Currently being treated with any oral anti-diabetes agents other than Sulphonylurea or Biguanides or being treated with insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: mix probiotic supplementationmix probiotic | Dietary supplement | probiotic |
| Placeboplacebo | Dietary supplement | placebo |
Primary outcome
Hb A1c
Time frame: 3 months
1 secondary outcome
inflammatory markers
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Derived from this study: PubMed 37870148Cooper 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.
- Derived from this study: PubMed 26654906Firouzi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Somayyeh Firouzi, Master principal investigator
Nutrition and Dietetic department, University Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Type 2 Diabetes Mellitus and Obesity, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Somayyeh Firouzi, master (0060-172118565, firouzi.som@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hb A1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01752803, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.