Trial Outcomes & Findings for Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes (NCT NCT02635646)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

122 participants

Primary outcome timeframe

6 months

Results posted on

2019-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	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. 56 patients were included in this group	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. 58 patients were included in this group
Overall Study STARTED	57	65
Overall Study COMPLETED	32	39
Overall Study NOT COMPLETED	25	26

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 56 patients were included in this group	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. 58 patients were included in this group
Overall Study Lost to Follow-up	24	25
Overall Study Pregnancy	1	1

Baseline Characteristics

Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Family and Interdisciplinary Approach n=57 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: 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 n=65 Participants 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.	Total n=122 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 13 • n=5 Participants	46 years STANDARD_DEVIATION 12 • n=7 Participants	44 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	34 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	57 Participants n=5 Participants	65 Participants n=7 Participants	122 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	Family and Interdisciplinary Approach n=42 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: 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 patients were included in this group	Individual Approach n=48 Participants 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: 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 patients were included in this group
Individual Insulin Resistance and Insulin Secretion	4.9 score on a scale Standard Deviation 3.5	4.8 score on a scale Standard Deviation 2.6

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Family and Interdisciplinary Approach n=32 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: 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 patients were included in this group	Individual Approach n=39 Participants 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: 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 patients were included in this group
Individual Insulin Resistance and Insulin Secretion	4.7 score on a scale Standard Deviation 3.5	4.9 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 12 months

Population: Matsuda Index measured in the relatives of the patients at the end of the study (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).

Outcome measures

Outcome measures
Measure	Family and Interdisciplinary Approach n=23 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: 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 patients were included in this group	Individual Approach n=7 Participants 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: 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 patients were included in this group
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	4.6 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 12 months

Weight in the relatives of the patients

Outcome measures

Outcome measures
Measure	Family and Interdisciplinary Approach n=23 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: 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 patients were included in this group	Individual Approach n=7 Participants 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: 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 patients were included in this group
Weight	65.4 kg Standard Deviation 16.8	75.0 kg Standard Deviation 16.0

SECONDARY outcome

Timeframe: 6 and 12 months

Measurement of 2h post OGTT glucose

Outcome measures

Outcome measures
Measure	Family and Interdisciplinary Approach n=32 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: 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 patients were included in this group	Individual Approach n=39 Participants 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: 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 patients were included in this group
2h OGTT Glucose 2h Glucose at 6 months	135 mg/dl Standard Deviation 35	131 mg/dl Standard Deviation 45
2h OGTT Glucose 2h Glucose at 12 months	142 mg/dl Standard Deviation 33	127 mg/dl Standard Deviation 33

Adverse Events

Family and Interdisciplinary Approach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Individual Approach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rodolfo Guardado-Mendoza

University of Guanajuato

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place