Protein Supplementation for Gestational Diabetes

SS
BP
Overseen ByBrock Polnaszek, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether high-protein beverages during labor can better control blood sugar in pregnant women using insulin for diabetes. It also examines the effects of these drinks on energy levels and the birth experience. Researchers will compare the results with those of women who drink standard clear liquids like juice or broth. Women using insulin for diabetes during a single pregnancy and undergoing labor induction are ideal candidates for this trial. Participants will wear a glucose sensor and provide feedback on their experience. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance labor experiences for women with diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. Since the study involves women with insulin-treated diabetes, it seems likely that you will continue your insulin therapy during the trial.

What prior data suggests that high-protein beverages are safe for pregnant women with insulin-treated diabetes?

In a previous study, researchers examined the effects of high-protein drinks on blood sugar levels in pregnant women to determine if these drinks could help manage gestational diabetes. The results indicated that increased protein intake might lower the risk of developing gestational diabetes during pregnancy.

Regarding safety, pregnant women generally tolerate protein drinks well. The reviewed studies did not report any major side effects from these drinks, suggesting that high-protein drinks are likely safe during pregnancy. However, it is important to monitor any unusual symptoms and inform a healthcare provider if they occur.12345

Why are researchers excited about this trial?

Unlike the standard treatments for gestational diabetes, which often involve dietary management and insulin therapy, the high-protein supplementation in this trial offers a unique approach. The Genius Gourmet Sparkling Protein Water provides a significant protein boost with zero carbohydrates and fats, potentially helping to stabilize blood sugar levels without additional glucose intake. Researchers are excited because this beverage could offer a more convenient and less invasive option for managing gestational diabetes, especially during labor, by delivering essential nutrients without impacting blood sugar.

What evidence suggests that high-protein beverages might be an effective treatment for gestational diabetes?

Research has shown that consuming whey protein before meals can help lower blood sugar levels in women with gestational diabetes (GDM). Studies have found that whey protein intake before eating reduces the typical post-meal blood sugar spike. Specifically, women with GDM experienced a noticeable drop in their peak blood sugar levels when they consumed whey protein before meals. This trial will compare a High-Protein Supplementation arm, where participants receive a high-protein beverage, with a Standard Clear Liquid Diet arm. High-protein drinks might help stabilize blood sugar during labor. Additionally, evidence suggests that increased protein intake may lower the risk of developing gestational diabetes. These findings support the idea that protein supplements could help manage blood sugar during pregnancy.13678

Are You a Good Fit for This Trial?

This trial is for pregnant women age 18 or older with gestational diabetes or Type 2 diabetes treated with insulin, carrying one baby, at least 37 weeks along, and admitted to the hospital to be induced for labor. Participants must be able and willing to give consent.

Inclusion Criteria

I have gestational diabetes or Type 2 diabetes and need insulin during pregnancy.
I am 18 years old or older.
* Singleton pregnancy
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either high-protein nutritional supplements or standard clear liquids during labor, with continuous glucose monitoring from admission through delivery.

Up to 72 hours
Continuous monitoring during labor

Postpartum Monitoring

Participants continue to wear a continuous glucose monitor for up to 7 days postpartum to assess glucose control.

7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including maternal and neonatal outcomes.

Up to 6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

  • High-Protein Beverage

Trial Overview

The study compares drinking a high-protein beverage every 4 hours during labor versus standard clear liquids (like juice or broth) in women with insulin-treated diabetes. Blood sugar will be tracked using a small sensor on the arm.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: High-Protein SupplementationExperimental Treatment2 Interventions
Group II: Standard Clear Liquid DietActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Citations

Once-daily supplementation with pre-meal whey protein ...

Once-daily supplementation with pre-meal whey protein lowers breakfast postprandial glucose levels in women with GDM throughout the third ...

Premeal Whey Protein Lowers Postprandial Blood Glucose in ...

Premeal whey consumption acutely lowers postprandial blood glucose in women with GDM and those with NGT, with 15–30 g lowering the glucose iAUC of women with ...

Association between protein intake and risk of gestational ...

The analysis revealed a significant association between total protein intake during pregnancy and an elevated risk of GDM (relative risk (RR): 2.24, 95 % ...

Protein Supplementation for Gestational Diabetes

The goal of this study is to learn if high-protein drinks during labor can improve blood sugar control in pregnant women with ...

Fueling Labor: Protein Supplementation for Intrapartum ...

The goal of this study is to learn if high-protein drinks during labor can improve blood sugar control in pregnant women with ...

Beverage Intake and the Risk of Gestational Diabetes Mellitus

This study investigated the association between the quantity and types of beverages with gestational diabetes mellitus (GDM) risk.

Beverage Intake and the Risk of Gestational Diabetes ...

While higher intake of cultured-milk drinks was associated with an increased risk of GDM, higher fruit juice intake was associated with a lower risk of GDM.

Protein Supplementation for Intrapartum Glucose Control

The goal of this study is to learn if high-protein drinks during labor can improve blood sugar control in pregnant women with ...