CLINICAL TRIAL

Lifestyle Intervention for Gestational Diabetes Mellitus (GDM)

Recruiting · 18+ · Female · New Orleans, LA

Maternal Health Diabetes Prevention Study

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About the trial for Gestational Diabetes Mellitus (GDM)

Eligible Conditions
Gestational Diabetes Mellitus (GDM) · Diabetes Mellitus · Glucose tolerance impaired in pregnancy · Hyperglycemia · Diabetes, Gestational · PreDiabetes · Glucose Intolerance

Treatment Groups

This trial involves 2 different treatments. Lifestyle Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Lifestyle Intervention
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Intervention
2001
Completed Phase 2
~8800

Side Effect Profile for Metformin

Metformin
Show all side effects
35%
Diarrhea
22%
headache/migraine
22%
common cold/respiratory tract infection
16%
nausea and/or vomiting
15%
flu
13%
dysmenorrhea/cramps
11%
stomach/abdominal pain or discomfort
9%
musculoskeletal
5%
dizziness
5%
hair loss
5%
vaginal infection
5%
dental issues
4%
fatigue
4%
flatulence
2%
bladder infection
0%
altered mood/mood swings
0%
allergic reaction
Diarrhea
35%
headache/migraine
22%
common cold/respiratory tract infection
22%
nausea and/or vomiting
16%
flu
15%
dysmenorrhea/cramps
13%
stomach/abdominal pain or discomfort
11%
musculoskeletal
9%
dizziness
5%
hair loss
5%
vaginal infection
5%
dental issues
5%
fatigue
4%
flatulence
4%
bladder infection
2%
altered mood/mood swings
0%
allergic reaction
0%
This histogram enumerates side effects from a completed 2008 Phase 2 trial (NCT00151411) in the Metformin ARM group. Side effects include: Diarrhea with 35%, headache/migraine with 22%, common cold/respiratory tract infection with 22%, nausea and/or vomiting with 16%, flu with 15%.

Eligibility

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Medical record documented diagnosis of GDM during most recent pregnancy
Access to a device that can access the internet
English speaking
Age ≥18 years
The baby is 6 weeks to 12 months old. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Lifestyle Intervention will improve 1 primary outcome, 5 secondary outcomes, and 11 other outcomes in patients with Gestational Diabetes Mellitus (GDM). Measurement will happen over the course of 8-week intervention.

Fidelity - sessions held
8-WEEK INTERVENTION
Number of sessions held throughout the 8 week intervention
8-WEEK INTERVENTION
Staff time involved in recruitment
PRE-ENROLLMENT (BEFORE ENROLLMENT INTO THE STUDY)
PRE-ENROLLMENT (BEFORE ENROLLMENT INTO THE STUDY)
Recruitment yield
PRE-ENROLLMENT (BEFORE ENROLLMENT INTO THE STUDY)
Yield of participants recruited (out of number of prescreening calls, screening visits)
PRE-ENROLLMENT (BEFORE ENROLLMENT INTO THE STUDY)
Fidelity - session content
8-WEEK INTERVENTION
Assessment of whether key concepts were covered during sessions
8-WEEK INTERVENTION
Fidelity - sessions attended
8-WEEK INTERVENTION
Number of sessions attended throughout the 8 week intervention
8-WEEK INTERVENTION
Intervention appropriateness
2-MONTH DATA COLLECTION VISIT
Appropriateness questionnaire delivered to participants and staff delivering the intervention
2-MONTH DATA COLLECTION VISIT
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of gestational diabetes mellitus (gdm)?

Nausea occurring during pregnancy is common, but is not a reliable symptom of GDM. The diagnosis of GDM is only made on a random blood glucose or fasting glucose test.

Anonymous Patient Answer

How many people get gestational diabetes mellitus (gdm) a year in the United States?

The ACS calculated that 4.3 million women would develop gdm during pregnancy and 0.76 % of maternal diabetes pregnancies result in stillbirth or low birth weight delivery. Also, 24.9 % of diabetic pregnancies will end in stillbirth or low birth weight delivery annually.

Anonymous Patient Answer

What causes gestational diabetes mellitus (gdm)?

[Women can lose up to 10% of their body weight between 2 weeks and 6 months before they are expected to conceive as a result of changes in their hormonal levels. When their blood sugar levels in the early weeks are low, the body responds by producing insulin, the insulin-producing pancreas responds by producing insulin and by storing new cells in the body to produce insulin later on. As body weight remains at or above the expected level, more insulin is produced, and, as body fat is not converted into insulin as fast as it could be, insulin production is slowed down. One thing keeps it from being absorbed by the cells in the body is the blood vessels that move the insulin from the pancreas into the bloodstream.

Anonymous Patient Answer

What is gestational diabetes mellitus (gdm)?

Gestational diabetes is a common problem during late pregnancy, and most of these women will not suffer complications from gestational diabetes. It does, however, carry a moderate to high risk for future development of atherosclerosis and hypertension after delivery. It is also a risk factor for maternal and fetal morbidity. We therefore recommend that GDM be considered in women with signs and symptoms of gestational hypertension or placental insufficiency in late pregnancy.

Anonymous Patient Answer

Can gestational diabetes mellitus (gdm) be cured?

In a recent study, findings of this study show that a sustained reduction of insulin resistance and the need for insulin in patients who were previously insulin dependent in early pregnancy are seen in a large percentage of the study group. In addition, most pregnancies in our study show sustained resolution of gdm, mostly without additional intervention.

Anonymous Patient Answer

What are common treatments for gestational diabetes mellitus (gdm)?

There are many commonly used treatments in the prenatal management of (gdm); these treatments include the use of exercise, diet, and gestational weight loss. The use of acupuncture is also frequently prescribed to treat gestational gdm, as well as dysmenorrhea and dyspareunia. For obese patients, weight loss programmes can also be prescribed to decrease or stop gdm. Gdm is estimated to affect approximately 70% of pregnant women in industrialized nations. The incidence of treatment with diet, exercise, or weight loss is similar among the population of women with gdm.

Anonymous Patient Answer

What is lifestyle intervention?

The impact of lifestyle intervention varies dramatically even in the context of the same diabetes condition. It is important to evaluate not only the degree of improvement, but also the impact on other patient-carerelated factors.

Anonymous Patient Answer

What is the primary cause of gestational diabetes mellitus (gdm)?

Of pregnant women with IGT by OGTT, the primary cause of gdm is insulin resistance rather than GDM per se, with the possibility that gestational obesity may aggravate both.

Anonymous Patient Answer

Does lifestyle intervention improve quality of life for those with gestational diabetes mellitus (gdm)?

In a recent study, findings provide evidence that an intervention that aims to promote both lifestyle choices by patients and clinicians improves the HRQoL of the target population.

Anonymous Patient Answer

Does gestational diabetes mellitus (gdm) run in families?

These data suggest that genetic predisposition to GDM runs at least among some of the affected families in the Scandinavian population. The genetic risk for GDM appears to be determined mainly by the number of affected children in an affected pedigree, with no other detectable contribution.

Anonymous Patient Answer

What are the latest developments in lifestyle intervention for therapeutic use?

Lifestyle therapies to treat obesity are evolving to target the metabolic, lifestyle and physical aspects of the patient's condition. The combination of these factors may provide substantial reductions in the symptoms of morbid obesity. The combination of a low calorie diet with the addition of exercise leads to improvement in obesity-induced comorbid conditions such as hyperlipidemia, hypertension and type II diabetes. Moreover, the combination of exercise with cognitive-behavioural modification (C-B-M) leads to the greatest improvement in weight, obesity-induced comorbid conditions and quality of life.

Anonymous Patient Answer

How serious can gestational diabetes mellitus (gdm) be?

GDM is one of the most common chronic medical problems during pregnancy. However, gestational diabetes mellitus has many severe, even maternal and fetal, complications including stillbirths, preterm deliveries, and low birth weights. To prevent these complications, it is very important to diagnose early and follow up carefully with patients in order to control their glycemia. There is no one ideal treatment for gestational diabetes. But there are many medications and diets that have been approved for use in diabetic pregnancy.

Anonymous Patient Answer
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