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| Name | Class |
|---|---|
| University of Texas | OTHER |
| National Council of Science and Technology, Mexico | OTHER |
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The purpose of the study is to evaluate the effect of a family and interdisciplinary approach on individual and family insulin resistance and insulin secretion in patients with prediabetes.
This a randomized clinical trial designed to evaluate the efficacy of the following treatments:
To improve individual and family insulin resistance and insulin secretion in patients with prediabetes.
Patients will have a follow-up visit every month in the Metabolic Research Laboratory at the University of Guanajuato, Mexico, and will have a fasting measurement of lipids, glucose and insulin every 3 months, as well as 2h oral glucose tolerance test (OGTT) at basal, 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family and interdisciplinary approach | Experimental | Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months |
|
| individual approach | Active Comparator | individual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family and interdisciplinary approach | Other | Family and interdisciplinary approach that includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| Individual Insulin Resistance and Insulin Secretion | Whole body insulin sensitivity as determined by the Matsuda Index was calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity (better result). A value of 2.5 or less is indicative of low insulin sensitivity (worst result). | 6 months |
| Individual Insulin Resistance and Insulin Secretion | Whole body insulin sensitivity as determined by the Matsuda Index was calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher values indicating better insulin sensitivity (better result, the higher the value the better the result of this variable). A value of 2.5 or less is indicative of low insulin sensitivity (worst result). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients) | Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity (the higher the value the better the result). A value of 2.5 or less is indicative of low insulin sensitivity (worst result). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodolfo Guardado, Dr | Universidad de Guanajuato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Guanajuato | León | Guanajuato | 37670 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Family and Interdisciplinary Approach | Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months Family and interdisciplinary approach: Family and interdisciplinary approach that includes:
56 patients were included in this group |
| FG001 | Individual Approach | Iindividual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months Individual approach: Individual approach that includes:
58 patients were included in this group |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Family and Interdisciplinary Approach | Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months Family and interdisciplinary approach: Family and interdisciplinary approach that includes:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Individual Insulin Resistance and Insulin Secretion | Whole body insulin sensitivity as determined by the Matsuda Index was calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity (better result). A value of 2.5 or less is indicative of low insulin sensitivity (worst result). | The analysis was performed only in patients completing the 6 month follow-up, since there were patients lost during the follow-up by drop-outs | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
Adverse events were collected during 1 year
Non serious adverse evens were expected to occur during this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Family and Interdisciplinary Approach | Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months Family and interdisciplinary approach: Family and interdisciplinary approach that includes:
56 patients were included in this group |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rodolfo Guardado-Mendoza | University of Guanajuato | guardamen@gmail.com |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| individual approach | Other | individual approach that includes:
|
|
| 12 months |
| Weight | Weight in the relatives of the patients | 12 months |
| 2h OGTT Glucose | Measurement of 2h post OGTT glucose | 6 and 12 months |
| BG001 | Individual Approach | Iindividual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months Individual approach: Individual approach that includes:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months Family and interdisciplinary approach: Family and interdisciplinary approach that includes:
57 patients were included in this group |
| OG001 | Individual Approach | individual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months individual approach: Individual approach that includes:
65 patients were included in this group |
|
|
|
| Primary | Individual Insulin Resistance and Insulin Secretion | Whole body insulin sensitivity as determined by the Matsuda Index was calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher values indicating better insulin sensitivity (better result, the higher the value the better the result of this variable). A value of 2.5 or less is indicative of low insulin sensitivity (worst result). | Only the patients that completed the 12-months follow-up were included in this analysis, since some patients drop-out from the study before the 12-months follow-up. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| Secondary | Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients) | Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity (the higher the value the better the result). A value of 2.5 or less is indicative of low insulin sensitivity (worst result). | Matsuda Index measured in the relatives of the patients at the end of the study (12 months) | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| Secondary | Weight | Weight in the relatives of the patients | Posted | Mean | Standard Deviation | kg | 12 months |
|
|
|
|
| Secondary | 2h OGTT Glucose | Measurement of 2h post OGTT glucose | Posted | Mean | Standard Deviation | mg/dl | 6 and 12 months |
|
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | Individual Approach | Iindividual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months Individual approach: Individual approach that includes:
58 patients were included in this group | 0 | 65 | 0 | 65 |
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| D004700 | Endocrine System Diseases |