Medical Nutrition Therapy Program for Pregnant Women With Diabetes
This study has been completed.
Sponsor:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Information provided by:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier:
NCT00860613
First received: March 11, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Gestational Diabetes Type 2 Diabetes |
Other: medical nutrition therapy program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:
Primary Outcome Measures:
- metabolic control [ Time Frame: every two weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- maternal nutritional status [ Time Frame: every two weeks ] [ Designated as safety issue: No ]
- fetal nutritional status [ Time Frame: at labor ] [ Designated as safety issue: No ]
- cost effectiveness [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 162 |
| Study Start Date: | February 2004 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
|
Other: medical nutrition therapy program
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.
|
|
Experimental: 2
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.
|
Other: medical nutrition therapy program
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.
|
|
No Intervention: 3
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860613
Locations
| Mexico | |
| Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes | |
| Mexico, Mexico City, Mexico, 11700 | |
Sponsors and Collaborators
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Investigators
| Study Chair: | Felipe Vadillo-Ortega, M.D, PhD | Instituto Nacional de Perinatología Isidro Espionosa de los Reyes |
| Principal Investigator: | Otilia Perichart-Perera, M.S, RD | Instituto Nacional de Perinatología Isidro Espionosa de los Reyes |
| Study Chair: | Margie Balas-Nakash, B.S | Instituto Nacional de Perinatología Isidro Espionosa de los Reyes |
| Study Chair: | Adalberto Parra-Covarrubias, M.D | Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes |
| Study Chair: | Ameyalli Rodriguez-Cano, B.S | Instituto Nacional de Perinatología Isidro Espinosa de los Reyes |
More Information
No publications provided
| Responsible Party: | Otilia Perichart Perera, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes |
| ClinicalTrials.gov Identifier: | NCT00860613 History of Changes |
| Other Study ID Numbers: | 212250-02091 |
| Study First Received: | March 11, 2009 |
| Last Updated: | March 11, 2009 |
| Health Authority: | Mexico: Ministry of Health |
Keywords provided by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:
|
gestational diabetes medical nutrition therapy program glucose monitoring |
metabolic control nutritional status cost effectiveness |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pregnancy Complications |
ClinicalTrials.gov processed this record on June 18, 2013