PrediabetesCARE-in-DEEPNCT02635646
Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes
A study testing Family and interdisciplinary approach and individual approach in people with Prediabetes, run by Universidad de Guanajuato at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Family and interdisciplinary approach and individual approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Type 2 diabetes
- Pregnancy
- Liver disease
- Renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Family and Interdisciplinary Intervention to Prevent Diabetes, and Effect on Family Profiles of Insulin Secretion and Insulin Resistance in Patients With Prediabetes
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.
Read the detailed description
This a randomized clinical trial designed to evaluate the efficacy of the following treatments:
- Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months
- 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.
- Conditions
- Prediabetes
- Being tested
- Family and interdisciplinary approach, individual approach
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family and interdisciplinary approachOther
Family and interdisciplinary approach that includes:
- nutritional counseling,
- physical activity counseling,
- psychological counseling,
- 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 approachOther
individual approach that includes:
- nutritional and physical activity counseling in individual appointments,
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Family and interdisciplinary approach |
| 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 Receives: Other: individual approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 12 months
Secondary outcomes (3)
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).
Measured: 12 months
Weight
Weight in the relatives of the patients
Measured: 12 months
2h OGTT Glucose
Measurement of 2h post OGTT glucose
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Rodolfo Guardado Mendoza, Universidad de Guanajuato
- Investigators
- Rodolfo Guardado, Dr, Principal investigator, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635646
- Sponsor's protocol ID
- UG 1/2014
- Acronym
- CARE-in-DEEP
- Status last verified
- Jun 2019
- First submitted
- 15 Dec 2015
- Last updated
- 29 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Family and Interdisciplinary Intervention to Prevent Diabetes, and Effect on Family Profiles of Insulin Secretion and Insulin Resistance in Patients With Prediabetes
- ClinicalTrials.gov ID
- NCT02635646
- Acronym / sponsor ID
- CARE-in-DEEP / UG 1/2014
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Collaborators
- University of Texas, National Council of Science and Technology, Mexico
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Posted 8 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family and interdisciplinary approach | Experimental | Other: Family and interdisciplinary approachFamily 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 | Other: individual approachindividual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Type 2 diabetes
- Pregnancy
- Liver disease
- Renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family and interdisciplinary approachFamily 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. | Other | Family and interdisciplinary approach |
| individual approachindividual 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. | Other | individual approach |
Primary outcome
Individual Insulin Resistance and Insulin Secretion
Time frame: 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).
Individual Insulin Resistance and Insulin Secretion
Time frame: 12 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 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).
3 secondary outcomes
Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients)
Time frame: 12 months
Weight
Time frame: 12 months
2h OGTT Glucose
Time frame: 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodolfo Guardado, Dr principal investigator
Universidad de Guanajuato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family and interdisciplinary approach and individual approach in people with Prediabetes, run by Universidad de Guanajuato at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual Insulin Resistance and Insulin Secretion (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.