Diabetes Mellitus Type 2 in ObeseNCT03904901
Influence of Probiotics in Diabetic Cardiopathies With Excessive Weight
A study testing Probiotics in people with Diabetes Mellitus Type 2 in Obese and Anxiety, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Today in Brazil, 6.9% of the population has Diabetes Mellitus 2 (DM2). In the world, there are about 422 million people with DM2. It is a chronic disease of the endocrine system, accounts for 90 to 95% of cases of DM2 and is characterized by defects in insulin action and secretion. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Diabetes Mellitus Type 2 in Obese, Anxiety, Cardiopathy
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2018to Jun 2019
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 60 years;
- BMI greater than 25 m² / kg and less than 40 m² / kg;
- DM2.
Who cannot join
- Use of antibiotics or medications for weight loss purposes;
- Use of kefir, yacult;
- Lactose intolerance;
- Inflammatory bowel disease;
- Valvar surgery;
- Use of laxative in the last 3 months;
- Patients participating in other clinical studies.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Suelen Dallanora
Porto Alegre, Rio Grande do Sul, 90620000
Suelen Dallanora, 55996630616, suu_dallanora@hotmail.com
About this study
Official title: Influence of Probiotics in Nutritional, Biochemical Profile and Anxiety of Diabetic Cardiopathies With Excessive Weight: a Randomized Clinical Test
Today in Brazil, 6.9% of the population has Diabetes Mellitus 2 (DM2). In the world, there are about 422 million people with DM2. It is a chronic disease of the endocrine system, accounts for 90 to 95% of cases of DM2 and is characterized by defects in insulin action and secretion. Its main cause is linked to obesity and insulin resistance. Obesity is a chronic, multifactorial disease - environmental, nutritional and genetic factors - characterized by excessive accumulation of body fat, and is reaching epidemic proportions, more than 100 million children and 600 million adults worldwide. The number of obese people in Brazil reaches 17.9% of the population.
Rates of obesity and DM2 have increased in the last decades, both diseases being associated with inflammation and specific alterations in the intestinal microbiota. Thus, studies show that the use of probiotics may be associated with reduced body weight and reduced glucose in the bloodstream. Probiotics are living microorganisms that, when administered in suitable dosages, confer benefits to the health of the host. In addition, studies show the relationship of the intestinal microbiota and the emergence of various diseases and demonstrate that probiotics can control inflammatory processes, metabolic dysfunctions, normalization of stress-induced behaviors, regulation of the hypothalamic-pituitary-adrenal axis and neuropsychiatric disorders. Thus, the importance of investigating the ingestion of probiotics in relation to anthropometry, biochemical profile and anxiety in diabetic and overweight individuals with cardiopathy are justified. It is a randomized, double-blind, controlled clinical trial. The study will last 3 months and will occur with 74 adult individuals (between 20 and 60 years) of the SUS outpatient clinic of the Institute of Cardiology of Porto Alegre - RS, of both sexes, with BMI above 25 m² / kg. and less than 40 m² / kg, divided into 2 groups and 37 individuals per group. These patients were: Group A (intervention: n = 37): patient received 1 sachet per day of probiotics Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum for 90 days and Group B (placebo; n = 37): microcrystalline cellulose, lactose, pregelatinized maize starch. Probiotics will contain a dose of 109 CFU in each strain. The excipients used will be: microcrystalline cellulose.
Read the detailed description
Probióticos
- Conditions
- Diabetes Mellitus Type 2 in Obese, Anxiety, Cardiopathy
- Being tested
- Probiotics, Placebo
- Medical subject headings
- Anxiety Disorders, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Individuals will receive individual capsules containing the daily dose of lyophilized probiotics (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum) and will be advised to remain at room temperature, ingest with water and drink before bed.
PlaceboDietary supplement
The placebo product had only the excipient, microcrystalline cellulose, and was identical to the active product in relation to color, shape, size and packaging.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Individuals will receive individual capsules containing the daily dose of lyophilized probiotics (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum) and will be advised to remain at room temperature, drink with water and drink before bed. Probiotics contain a dose of 10 9 CFU per capsule. Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | The placebo product had only the excipient, microcrystalline cellulose, and was identical to the active product in relation to color, shape, size and packaging. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of DM2
Blood samples were collected fasting (12h overnight) to determine glycemic and hemoglobin (HbA1c)
Measured: 3 months
Anxety
To assess anxiety, was applied by a psychologist to the Beck Scale.
BAI consists of 21 questions about how the individual has felt in the past week, expressed in common anxiety symptoms (such as sweating and feelings of distress). Each question presents four possible answers, and the one that most closely resembles the individual's mental state must be signaled. The possible answers are:
Not; Lightly: did not bother me too much; Moderately: it was unpleasant, but I could bear it; Severely: I hardly supported.
BAI can have a maximum score of 63 and the categories are:
0-10: minimum degree of anxiety; 11-19: mild anxiety; 20-30 moderate anxiety; Severe anxiety 31-63.
Measured: 3 months
Secondary outcomes (4)
Alteration of serum lipids
Blood samples were collected fasting (fasting of 12h overnight) for glycemia, glycated hemoglobin (HbA1c) in mg / dL, total cholesterol (TC) in mg / dL, high density lipoprotein (HDL-c) in mg / dL, non-HDL in mg / dL and triglycerides in mg / dL. Levels of low-density lipoprotein (LDL in mg / dL) were determined by the Friedewal formula. LDL-c (mg / dL) = TC (mg / dL) - HDL-c (mg / dL) - TG (mg / dL) / 5.
Measured: 3 months
Weight
Body weights were measured using a portable digital scale (Omron brand) without shoes and minimal clothing.
Measured: 3 months
Height
The heights were measured with tape measure fixed to the wall.
Measured: 3 months
BMI
BMI was calculated by dividing body weight (in kilograms) by height (in meters) squared.
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 posted5 Apr 2019
- Study start20 Jul 2018
- Primary completionMay 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 in ObeseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suelen Dallanora, Study director, Instituto de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904901
- Sponsor's protocol ID
- SDallanora
- Status last verified
- Apr 2019
- First submitted
- 25 Oct 2018
- Last updated
- 5 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Probiotics in Nutritional, Biochemical Profile and Anxiety of Diabetic Cardiopathies With Excessive Weight: a Randomized Clinical Test
- ClinicalTrials.gov ID
- NCT03904901
- Acronym / sponsor ID
- SDallanora
- Conditions
- Diabetes Mellitus Type 2 in Obese, Anxiety, Cardiopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 5 Apr 2019 (actual)
- 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.
Today in Brazil, 6.9% of the population has Diabetes Mellitus 2 (DM2). In the world, there are about 422 million people with DM2. It is a chronic disease of the endocrine system, accounts for 90 to 95% of cases of DM2 and is characterized by defects in insulin action and secretion. Its main cause is linked to obesity and insulin resistance. Obesity is a chronic, multifactorial disease - environmental, nutritional and genetic factors - characterized by excessive accumulation of body fat, and is reaching epidemic proportions, more than 100 million children and 600 million adults worldwide. The number of obese people in Brazil reaches 17.9% of the population.
Rates of obesity and DM2 have increased in the last decades, both diseases being associated with inflammation and specific alterations in the intestinal microbiota. Thus, studies show that the use of probiotics may be associated with reduced body weight and reduced glucose in the bloodstream. Probiotics are living microorganisms that, when administered in suitable dosages, confer benefits to the health of the host. In addition, studies show the relationship of the intestinal microbiota and the emergence of various diseases and demonstrate that probiotics can control inflammatory processes, metabolic dysfunctions, normalization of stress-induced behaviors, regulation of the hypothalamic-pituitary-adrenal axis and neuropsychiatric disorders. Thus, the importance of investigating the ingestion of probiotics in relation to anthropometry, biochemical profile and anxiety in diabetic and overweight individuals with cardiopathy are justified. It is a randomized, double-blind, controlled clinical trial. The study will last 3 months and will occur with 74 adult individuals (between 20 and 60 years) of the SUS outpatient clinic of the Institute of Cardiology of Porto Alegre - RS, of both sexes, with BMI above 25 m² / kg. and less than 40 m² / kg, divided into 2 groups and 37 individuals per group. These patients were: Group A (intervention: n = 37): patient received 1 sachet per day of probiotics Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum for 90 days and Group B (placebo; n = 37): microcrystalline cellulose, lactose, pregelatinized maize starch. Probiotics will contain a dose of 109 CFU in each strain. The excipients used will be: microcrystalline cellulose.
Detailed description
Probióticos
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: ProbioticsIndividuals will receive individual capsules containing the daily dose of lyophilized probiotics (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum) and will be advised to remain at room temperature, drink with water and drink before bed. Probiotics contain a dose of 10 9 CFU per capsule. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo product had only the excipient, microcrystalline cellulose, and was identical to the active product in relation to color, shape, size and packaging. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20 and 60 years;
- BMI greater than 25 m² / kg and less than 40 m² / kg;
- DM2.
Key exclusion criteria (7 listed)
- Use of antibiotics or medications for weight loss purposes;
- Use of kefir, yacult;
- Lactose intolerance;
- Inflammatory bowel disease;
- Valvar surgery;
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 |
|---|---|---|
| ProbioticsIndividuals will receive individual capsules containing the daily dose of lyophilized probiotics (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum) and will be advised to remain at room temperature, ingest with water and drink before bed. | Dietary supplement | Probiotics |
| PlaceboThe placebo product had only the excipient, microcrystalline cellulose, and was identical to the active product in relation to color, shape, size and packaging. | Dietary supplement | Placebo |
Primary outcome
Control of DM2
Time frame: 3 months
Blood samples were collected fasting (12h overnight) to determine glycemic and hemoglobin (HbA1c)
Anxety
Time frame: 3 months
To assess anxiety, was applied by a psychologist to the Beck Scale. BAI consists of 21 questions about how the individual has felt in the past week, expressed in common anxiety symptoms (such as sweating and feelings of distress). Each question presents four possible answers, and the one that most closely resembles the individual's mental state must be signaled. The possible answers are: Not; Lightly: did not bother me too much; Moderately: it was unpleasant, but I could bear it; Severely: I hardly supported. BAI can have a maximum score of 63 and the categories are: 0-10: minimum degree of anxiety; 11-19: mild anxiety; 20-30 moderate anxiety; Severe anxiety 31-63.
4 secondary outcomes
Alteration of serum lipids
Time frame: 3 months
Weight
Time frame: 3 months
Height
Time frame: 3 months
BMI
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 5 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Suelen Dallanora study director
Instituto de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Diabetes Mellitus Type 2 in Obese and Anxiety, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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 3 inclusion and 7 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 5 Apr 2019. 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 Brazil. 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 Suelen Dallanora (5596630616, suu_dallanora@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of DM2 (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2019.