Prediabetes
Conditions
Brief summary
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.
Detailed description
This a randomized clinical trial designed to evaluate the efficacy of the following treatments: 1. Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months 2. Individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months 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.
Interventions
OTHERFamily and interdisciplinary 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.
OTHERindividual approach
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.
Sponsors
University of Texas
National Council of Science and Technology, Mexico
Universidad de Guanajuato
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with prediabetes (Fasting glucose 100-125mg/dl and/or 2h post OGTT glucose 140-199mg/dl) * Family of patients with prediabetes (in case of the patients that are randomized to FAMILY APPROACH) * Signing of the inform consent
Exclusion criteria
* Type 2 diabetes * Pregnancy * Liver disease * Renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Individual Insulin Resistance and Insulin Secretion | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients) | 12 months | 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). |
| Weight | 12 months | Weight in the relatives of the patients |
| 2h OGTT Glucose | 6 and 12 months | Measurement of 2h post OGTT glucose |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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:
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. | 57 |
| 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:
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. | 65 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 24 | 25 |
| Overall Study | Pregnancy | 1 | 1 |
Baseline characteristics
| Characteristic | Individual Approach | Total | Family and Interdisciplinary Approach |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 12 | 44 years STANDARD_DEVIATION 12 | 44 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 65 Participants | 122 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 31 Participants | 63 Participants | 32 Participants |
| Sex: Female, Male Male | 34 Participants | 59 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 65 |
| serious Total, serious adverse events | 0 / 57 | 0 / 65 |
Outcome results
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).
Time frame: 6 months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family and Interdisciplinary Approach | Individual Insulin Resistance and Insulin Secretion | 4.9 score on a scale | Standard Deviation 3.5 |
| Individual Approach | Individual Insulin Resistance and Insulin Secretion | 4.8 score on a scale | Standard Deviation 2.6 |
p-value: 0.844t-test, 2 sided
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).
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family and Interdisciplinary Approach | Individual Insulin Resistance and Insulin Secretion | 4.7 score on a scale | Standard Deviation 3.5 |
| Individual Approach | Individual Insulin Resistance and Insulin Secretion | 4.9 score on a scale | Standard Deviation 3 |
p-value: 0.624t-test, 2 sided
Secondary
2h OGTT Glucose
Measurement of 2h post OGTT glucose
Time frame: 6 and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Family and Interdisciplinary Approach | 2h OGTT Glucose | 2h Glucose at 6 months | 135 mg/dl | Standard Deviation 35 |
| Family and Interdisciplinary Approach | 2h OGTT Glucose | 2h Glucose at 12 months | 142 mg/dl | Standard Deviation 33 |
| Individual Approach | 2h OGTT Glucose | 2h Glucose at 6 months | 131 mg/dl | Standard Deviation 45 |
| Individual Approach | 2h OGTT Glucose | 2h Glucose at 12 months | 127 mg/dl | Standard Deviation 33 |
p-value: <0.05t-test, 2 sided
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).
Time frame: 12 months
Population: Matsuda Index measured in the relatives of the patients at the end of the study (12 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family and Interdisciplinary Approach | Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients) | 5.5 score on a scale | Standard Deviation 2.6 |
| Individual Approach | Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients) | 4.6 score on a scale | Standard Deviation 3.5 |
p-value: <0.05t-test, 2 sided
Secondary
Weight
Weight in the relatives of the patients
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family and Interdisciplinary Approach | Weight | 65.4 kg | Standard Deviation 16.8 |
| Individual Approach | Weight | 75.0 kg | Standard Deviation 16 |
p-value: 0.516t-test, 2 sided