Gestational DiabetesNCT00860613
Medical Nutrition Therapy Program for Pregnant Women With Diabetes
A study testing medical nutrition therapy program in people with Gestational Diabetes and Type 2 Diabetes, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
Trial summary
No dietary strategies have been designed and proved for Mexican pregnant women with diabetes. This is a randomized clinical trial of pregnant women with pregestational type 2 diabetes and gestational diabetes that were followed every two weeks until labor to assess the impact of the MNT program on metabolic control… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Type 2 Diabetes
- What is being tested?
- medical nutrition therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2004to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women with gestational diabetes (Freinkle´s classification: type A2 and B1) or pregestational type 2 diabetes.
- less than 30 weeks of gestation
- women who plan to attend their pregnancy at the institution (INPerIER)
Who cannot join
- women with type 1 pregestational diabetes or gestational diabetes type A1.
- women with multiple pregnancies
- women with renal or hepatic disease
- women who could not follow the dietary recommendations within the study
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Mexico City, Mexico City, 11700
About this study
Official title: Medical Nutrition Therapy Program for Pregnant Women With Diabetes: Evaluation of Two Different Dietary Strategies on Metabolic Control, Maternal and Fetal Nutritional Status and Cost Effectiveness.
No dietary strategies have been designed and proved for Mexican pregnant women with diabetes. This is a randomized clinical trial of pregnant women with pregestational type 2 diabetes and gestational diabetes that were followed every two weeks until labor to assess the impact of the MNT program on metabolic control, maternal and fetal nutritional status and cost effectiveness. Participants were randomly assigned to one of three medical nutrition therapy (MNT) groups: the MNT 1 group (n=38) received usual medical treatment, counseling from a nutritionist and diabetes educator, using carbohydrate counting (40-45% of carbohydrates)with an intensive educational component; MNT2 group (n=50) had the same treatment, but included only low-moderate glycemic index foods; and NO-MNT group (n=45) received the current hospital treatment. All women will receive a glucose meter so they do self glucose monitoring (pre and postprandial) 2 times a weeks 6 times a day. Weight gain, dietary consumption and glucose concentrations will be evaluated every two weeks. Fetal outcomes (weight, length and presence of complications)will be measured at labor.
- Conditions
- Gestational Diabetes, Type 2 Diabetes
- Being tested
- medical nutrition therapy program
- Keywords
- gestational diabetes, medical nutrition therapy program, glucose monitoring, metabolic control, nutritional status, cost effectiveness
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical nutrition therapy programOther
the dietary guidelines were based on the Nutrition Practice guidelines for gestational diabetes developed by the American Dietetic Association. Dietary strategies were based on carbohydrate counting and/or restriction of high glycemic index foods. Even carbohydrate distribution throughout the day was emphasized.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | women in this group received usual medical treatment and counseling from a nutritionist and diabetes educator. They received a specific diet using carbohydrate counting (40-45% of carbohydrates)and a moderate energy restriction. Weight gain, adequacy of diet, results of the self glucose monitoring, and ketonuria were evaluated every two weeks. They also received education on diabetes, diet and glucose monitoring. Receives: Other: medical nutrition therapy program |
| 2 | Experimental | Women in this group received usual medical treatment and counseling from a nutritionist and diabetes educator. The diet they received was based on carbohydrate counting (40-45% of carbohydrates), but recommended only low-moderate glycemic index foods. Weight gain, adequacy of diet, results of the self glucose monitoring, and ketonuria were evaluated every two weeks. They also received education on diabetes, diet and glucose monitoring. Receives: Other: medical nutrition therapy program |
| 3 | No intervention | women in this group received the current hospital treatment. They did not receive any intervention except for the self glucose monitoring that they did every two weeks. Weight gain and the results of the self glucose monitoring, were evaluated every two weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic control
Measured: every two weeks
Secondary outcomes (3)
maternal nutritional status
Measured: every two weeks
fetal nutritional status
Measured: at labor
cost effectiveness
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startFeb 2004
- Primary completionJun 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Sponsor type
- Other government
- Investigators
- Felipe Vadillo-Ortega, M.D, PhD, Study chair, Instituto Nacional de Perinatología Isidro Espionosa de los ReyesOtilia Perichart-Perera, M.S, RD, Principal investigator, Instituto Nacional de Perinatología Isidro Espionosa de los ReyesMargie Balas-Nakash, B.S, Study chair, Instituto Nacional de Perinatología Isidro Espionosa de los ReyesAdalberto Parra-Covarrubias, M.D, Study chair, Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesAmeyalli Rodriguez-Cano, B.S, Study chair, Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860613
- Sponsor's protocol ID
- 212250-02091
- Status last verified
- Mar 2009
- First submitted
- 11 Mar 2009
- Last updated
- 12 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Nutrition Therapy Program for Pregnant Women With Diabetes: Evaluation of Two Different Dietary Strategies on Metabolic Control, Maternal and Fetal Nutritional Status and Cost Effectiveness.
- ClinicalTrials.gov ID
- NCT00860613
- Acronym / sponsor ID
- 212250-02091
- Conditions
- Gestational Diabetes, Type 2 Diabetes
- Keywords
- gestational diabetes, medical nutrition therapy program, glucose monitoring, metabolic control, nutritional status, cost effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesOther government
- Study start
- Feb 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
No dietary strategies have been designed and proved for Mexican pregnant women with diabetes. This is a randomized clinical trial of pregnant women with pregestational type 2 diabetes and gestational diabetes that were followed every two weeks until labor to assess the impact of the MNT program on metabolic control, maternal and fetal nutritional status and cost effectiveness. Participants were randomly assigned to one of three medical nutrition therapy (MNT) groups: the MNT 1 group (n=38) received usual medical treatment, counseling from a nutritionist and diabetes educator, using carbohydrate counting (40-45% of carbohydrates)with an intensive educational component; MNT2 group (n=50) had the same treatment, but included only low-moderate glycemic index foods; and NO-MNT group (n=45) received the current hospital treatment. All women will receive a glucose meter so they do self glucose monitoring (pre and postprandial) 2 times a weeks 6 times a day. Weight gain, dietary consumption and glucose concentrations will be evaluated every two weeks. Fetal outcomes (weight, length and presence of complications)will be measured at labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: medical nutrition therapy programwomen in this group received usual medical treatment and counseling from a nutritionist and diabetes educator. They received a specific diet using carbohydrate counting (40-45% of carbohydrates)and a moderate energy restriction. Weight gain, adequacy of diet, results of the self glucose monitoring, and ketonuria were evaluated every two weeks. They also received education on diabetes, diet and glucose monitoring. |
| 2 | Experimental | Other: medical nutrition therapy programWomen in this group received usual medical treatment and counseling from a nutritionist and diabetes educator. The diet they received was based on carbohydrate counting (40-45% of carbohydrates), but recommended only low-moderate glycemic index foods. Weight gain, adequacy of diet, results of the self glucose monitoring, and ketonuria were evaluated every two weeks. They also received education on diabetes, diet and glucose monitoring. |
| 3 | No intervention | –women in this group received the current hospital treatment. They did not receive any intervention except for the self glucose monitoring that they did every two weeks. Weight gain and the results of the self glucose monitoring, were evaluated every two weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant women with gestational diabetes (Freinkle´s classification: type A2 and B1) or pregestational type 2 diabetes.
- less than 30 weeks of gestation
- women who plan to attend their pregnancy at the institution (INPerIER)
Key exclusion criteria (4 listed)
- women with type 1 pregestational diabetes or gestational diabetes type A1.
- women with multiple pregnancies
- women with renal or hepatic disease
- women who could not follow the dietary recommendations within the study
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 |
|---|---|---|
| medical nutrition therapy programthe dietary guidelines were based on the Nutrition Practice guidelines for gestational diabetes developed by the American Dietetic Association. Dietary strategies were based on carbohydrate counting and/or restriction of high glycemic index foods. Even carbohydrate distribution throughout the day was emphasized. | Other | 1, 2 |
Primary outcome
metabolic control
Time frame: every two weeks
3 secondary outcomes
maternal nutritional status
Time frame: every two weeks
fetal nutritional status
Time frame: at labor
cost effectiveness
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2009.
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
Felipe Vadillo-Ortega, M.D, PhD study chair
Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Otilia Perichart-Perera, M.S, RD principal investigator
Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Margie Balas-Nakash, B.S study chair
Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical nutrition therapy program in people with Gestational Diabetes and Type 2 Diabetes, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes 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 12 Mar 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
metabolic control (time frame: every two weeks). 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 12 Mar 2009.