Influence of Probiotics in Diabetic Cardiopathies With Excessive Weight
Primary Purpose
Diabetes Mellitus Type 2 in Obese, Anxiety, Cardiopathy
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Probiotics
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 in Obese
Eligibility Criteria
Inclusion Criteria:
- Age between 20 and 60 years;
- BMI greater than 25 m² / kg and less than 40 m² / kg;
- DM2.
Exclusion Criteria:
- 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.
Sites / Locations
- Suelen DallanoraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotics
Placebo
Arm Description
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.
The placebo product had only the excipient, microcrystalline cellulose, and was identical to the active product in relation to color, shape, size and packaging.
Outcomes
Primary Outcome Measures
Control of DM2
Blood samples were collected fasting (12h overnight) to determine glycemic and hemoglobin (HbA1c)
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.
Secondary Outcome Measures
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.
Weight
Body weights were measured using a portable digital scale (Omron brand) without shoes and minimal clothing.
Height
The heights were measured with tape measure fixed to the wall.
BMI
BMI was calculated by dividing body weight (in kilograms) by height (in meters) squared.
Full Information
NCT ID
NCT03904901
First Posted
October 25, 2018
Last Updated
April 4, 2019
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT03904901
Brief Title
Influence of Probiotics in Diabetic Cardiopathies With Excessive Weight
Official Title
Influence of Probiotics in Nutritional, Biochemical Profile and Anxiety of Diabetic Cardiopathies With Excessive Weight: a Randomized Clinical Test
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 in Obese, Anxiety, Cardiopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotics
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo product had only the excipient, microcrystalline cellulose, and was identical to the active product in relation to color, shape, size and packaging.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The placebo product had only the excipient, microcrystalline cellulose, and was identical to the active product in relation to color, shape, size and packaging.
Primary Outcome Measure Information:
Title
Control of DM2
Description
Blood samples were collected fasting (12h overnight) to determine glycemic and hemoglobin (HbA1c)
Time Frame
3 months
Title
Anxety
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Alteration of serum lipids
Description
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.
Time Frame
3 months
Title
Weight
Description
Body weights were measured using a portable digital scale (Omron brand) without shoes and minimal clothing.
Time Frame
3 months
Title
Height
Description
The heights were measured with tape measure fixed to the wall.
Time Frame
3 months
Title
BMI
Description
BMI was calculated by dividing body weight (in kilograms) by height (in meters) squared.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 20 and 60 years;
BMI greater than 25 m² / kg and less than 40 m² / kg;
DM2.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suelen Dallanora
Phone
5596630616
Email
suu_dallanora@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Barbiero
Phone
5184149328
Email
barbierosandra@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suelen Dallanora
Organizational Affiliation
Instituto de Cardiologia
Official's Role
Study Director
Facility Information:
Facility Name
Suelen Dallanora
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90620000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suelen Dallanora
Phone
55996630616
Email
suu_dallanora@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Probiotics in Diabetic Cardiopathies With Excessive Weight
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