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Gestational Diabetes Mellitus (GDM)LO-CANCT00911404

Carbohydrate Restriction for Gestational Diabetes Mellitus

A study testing Low CHO and High CHO diet in people with Gestational Diabetes Mellitus (GDM), run by Hospital Arnau de Vilanova at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is evidence that controlling total amount of carbohydrates is a strategy for controlling glucose levels in diabetes mellitus. There is not major evidence that any given macronutrient percentage may be recommended to treat a woman with Gestational Diabetes Mellitus (GDM). Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Gestational Diabetes Mellitus (GDM)
What is being tested?
Low CHO and High CHO diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteSpain
Study dates
Jan 2009to Jul 2012
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

  • Gestational diabetes mellitus
  • Single pregnancy

Who cannot join

  • Multiple pregnancy
  • High risk pregnancy (any other concomitant illness, excluding hypertension and obesity)
  • Low ability to understand and follow a diet
  • Need to use insulin different from regular insulin

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitari Arnau de Vilanova

    Lleida, Lleida, 25198

Other trials in Spain

About this study

Official title: Comparison of Two Different Diets Containing Different Proportions of Carbohydrates in the Treatment of Gestational Diabetes Mellitus: A Randomized Clinical Trial

There is evidence that controlling total amount of carbohydrates is a strategy for controlling glucose levels in diabetes mellitus. There is not major evidence that any given macronutrient percentage may be recommended to treat a woman with Gestational Diabetes Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy. Insulin treatment is more expensive and not as well accepted as MNT. The investigators have designed a randomized-controlled trial to assess whether a diet with 40% total calories from carbohydrates may reduce the need of insulin treatment in women with gestational diabetes, without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total calories from carbohydrates.

Being tested
Low CHO, High CHO diet
Keywords
Gestational diabetes, Carbohydrate, Diet, Insulin
Medical subject headings
Diabetes, Gestational, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low CHOBehavioural

    Diet with 40% total calories from carbohydrates. In the "Low-CHO" arm, 15% of calories from carbohydrates will be substituted by monounsaturated fat.

  • High CHO dietDietary supplement

    Diet with 55% total calories from carbohydrates.

Study groups in NCT00911404
Study groupRoleWhat they receive
Low CHOExperimentalDiet with 40% total calories from carbohydrates.
Receives: Behavioral: Low CHO
High CHOActive comparatorDiet with 55% total calories from carbohydrates.
Receives: Dietary Supplement: High CHO diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Need of insulin treatment for GDM

    Measured: Day of delivery

Secondary outcomes (4)

  1. Time from GDM diagnosis free of insulin treatment

    Measured: Day of delivery

  2. Maternal ketonemia and/or ketonuria

    Measured: Day of delivery

  3. Maternal morbidity

    Measured: Day of delivery

  4. Fetal morbidity

    Measured: 1 month after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

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
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00911404
Sponsor's protocol ID
CEIC-670
Acronym
LO-CA
Status last verified
Aug 2016
First submitted
28 May 2009
Last updated
23 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • Cypryk K, Kaminska P, Kosinski M, Pertynska-Marczewska M, Lewinski A. A comparison of the effectiveness, tolerability and safety of high and low carbohydrate diets in women with gestational diabetes. Endokrynol Pol. 2007 Jul-Aug;58(4):314-9.

    PubMed 18058723

  • Peterson CM, Jovanovic-Peterson L. Percentage of carbohydrate and glycemic response to breakfast, lunch, and dinner in women with gestational diabetes. Diabetes. 1991 Dec;40 Suppl 2:172-4. doi: 10.2337/diab.40.2.s172.

    PubMed 1748252

  • Major CA, Henry MJ, De Veciana M, Morgan MA. The effects of carbohydrate restriction in patients with diet-controlled gestational diabetes. Obstet Gynecol. 1998 Apr;91(4):600-4. doi: 10.1016/s0029-7844(98)00003-9.

    PubMed 9540949

  • Moreno-Castilla C, Hernandez M, Bergua M, Alvarez MC, Arce MA, Rodriguez K, Martinez-Alonso M, Iglesias M, Mateu M, Santos MD, Pacheco LR, Blasco Y, Martin E, Balsells N, Aranda N, Mauricio D. Low-carbohydrate diet for the treatment of gestational diabetes mellitus: a randomized controlled trial. Diabetes Care. 2013 Aug;36(8):2233-8. doi: 10.2337/dc12-2714. Epub 2013 Apr 5.

    PubMed 23564917

Questions about this trial

What is this clinical trial studying?

A study testing Low CHO and High CHO diet in people with Gestational Diabetes Mellitus (GDM), run by Hospital Arnau de Vilanova at 1 site in Spain.

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 2 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 23 Aug 2016. 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 Spain. 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?

Need of insulin treatment for GDM (time frame: Day of delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00911404, which also lists 4 linked publications.

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 23 Aug 2016; AzTrials last refreshed its copy on 4 Nov 2026.

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