An interventional study of Family and interdisciplinary approach and individual approach in Prediabetes, sponsored by Universidad de Guanajuato. Completed at 1 site in Mexico. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-29.
Sponsored by Universidad de Guanajuato · Not applicable, Interventional, and Prevention
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.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 122 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Universidad de Guanajuato is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Family and interdisciplinary 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
Other: individual approach
Family and interdisciplinary approach that includes: 1. nutritional counseling, 2. physical activity counseling, 3. psychological counseling, 4. metformin 850mg twice at day for 12 months All this with the purpose to improve insulin resistance and insulin secretion in patients with prediabetes. Patients must attend a monthly session together with his family where they will receive the nutritional, physical activity and psychological counseling.
individual approach that includes: 1. nutritional and physical activity counseling in individual appointments, 2. metformin 850mg twice at day for 12 months, All this with the purpose to improve insulin resistance and insulin secretion. The patients must attend a monthly follow-up individually.
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).
Time frame: 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).
Time frame: 12 months
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).
Time frame: 12 months
Weight
Weight in the relatives of the patients
Time frame: 12 months
2h OGTT Glucose
Measurement of 2h post OGTT glucose
Time frame: 6 and 12 months
| Milestone | Family and Interdisciplinary Approach | Individual Approach |
|---|---|---|
| Started | 57 | 65 |
| Completed | 32 | 39 |
| Not completed | 25 | 26 |
| Withdrew: Lost to follow-up | 24 | 25 |
| Withdrew: Pregnancy | 1 | 1 |
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).
| score on a scale | Family and Interdisciplinary Approach | Individual Approach |
|---|---|---|
| Individual Insulin Resistance and Insulin Secretion | 4.9 ± 3.5 | 4.8 ± 2.6 |
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).
| score on a scale | Family and Interdisciplinary Approach | Individual Approach |
|---|---|---|
| Individual Insulin Resistance and Insulin Secretion | 4.7 ± 3.5 | 4.9 ± 3.0 |
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).
| score on a scale | Family and Interdisciplinary Approach | Individual Approach |
|---|---|---|
| Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients) | 5.5 ± 2.6 | 4.6 ± 3.5 |
Weight in the relatives of the patients
| kg | Family and Interdisciplinary Approach | Individual Approach |
|---|---|---|
| Weight | 65.4 ± 16.8 | 75.0 ± 16.0 |
Measurement of 2h post OGTT glucose
| mg/dl | Family and Interdisciplinary Approach | Individual Approach |
|---|---|---|
| 2h Glucose at 6 months | 135 ± 35 | 131 ± 45 |
| 2h Glucose at 12 months | 142 ± 33 | 127 ± 33 |
Collected over Adverse events were collected during 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Family and Interdisciplinary Approach | — | 0/57 (0%) | 0/57 (0%) |
| Individual Approach | — | 0/65 (0%) | 0/65 (0%) |
| Age, Continuous(years) | Family and Interdisciplinary Approach | Individual Approach | Total |
|---|---|---|---|
| Mean | 44 ± 13 | 46 ± 12 | 44 ± 12 |
| Sex: Female, Male(Participants) | Family and Interdisciplinary Approach | Individual Approach | Total |
|---|---|---|---|
| Female | 32 | 31 | 63 |
| Male | 25 | 34 | 59 |
| Ethnicity (NIH/OMB)(Participants) | Family and Interdisciplinary Approach | Individual Approach | Total |
|---|---|---|---|
| Hispanic or Latino | 57 | 65 | 122 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad de Guanajuato