Impact of Antenatal Betamethasone on Plasma Glucose Levels



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 50
Updated:4/2/2016
Start Date:November 2007
Contact:Jennifer Jolley, MD
Email:jajolley@uwashington.edu

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It is known that administration of steroids increases blood sugar levels. Administration of
betamethasone is common practice during pregnancy to women at risk for preterm delivery.
However, it is unknown the magnitude of the changes in glucose these women have after
receiving betamethasone. The purpose of this study is to determine the magnitude and timing
of the increase in blood sugar in pregnant women without diabetes who receive steroids.

There is a substantial body of evidence that the administration of corticosteroids to
patients deemed to be at risk for preterm delivery (delivery prior to 37 weeks gestation)
decreases the risk of respiratory distress syndrome, intraventricular hemorrhage, and
neonatal death. Current recommendations from the National Institute of Health (NIH) and the
American College of Obstetricians and Gynecologists (ACOG) are that patients with
pregnancies that are between 24-34 weeks gestation deemed at risk for preterm delivery
receive antenatal corticosteroids. The recommended dosing is two doses of betamethasone 12
mg given 24 hours apart as an intramuscular injection. (Alternatively, dexamethasone 6 mg
given intramuscularly every 6 hours for 4 doses may be administered. Betamethasone is used
preferentially in our institution.)

Glucocortiocoids have a well-known effect on glucose metabolism. They increase blood glucose
levels by antagonizing insulin and decreasing synthesis of insulin, thus inhibiting
peripheral glucose utilization and increasing gluconeogenesis (the process by which the body
produces glucose). Pregnancy is also characterized by a relative insulin resistance that
results in glucose intolerance. It follows, then, that the combination of pregnancy and
corticosteroids could cause significant disruption of glucose homeostasis.

Routinely in pregnancy, gestational diabetes is diagnosed by the administration of a glucose
tolerance test consisting of ingestion of 50g of glucose followed by a serum glucose level
one hour later. This is known as a one-hour post-glucola test. A value of 140 mg/dL is
considered abnormal, and prompts administration of the 3-hour glucose tolerance test. This
test consists of a fasting blood sugar, followed by serum glucose levels after a 100g oral
glucose challenge at 1-, 2- and 3-hours. A profile with two or more abnormal values is
considered diagnostic for gestational diabetes. In 1997 Fisher et al retrospectively
compared the incidence of gestational diabetes in those patients who had received tocolytics
and antenatal corticosteroids to those who did not, and found a higher incidence of both
abnormal one-hour glucose screening tests and gestational diabetes in those patients who
received steroids and tocolytics (medications used to try to decrease uterine contractions).
However, the interval between the receipt of steroids and the administration of the glucose
screening test was quite variable in this study. Shelton et al in 2002 evaluated the extent
of hyperglycemia in non-diabetic patients who received multiple weekly doses of
corticosteroids. They found that the fasting glucose levels increased for several days
following the first course of steroids, returned to normal, and then remained persistently
elevated in those patients who received three or more courses. Postprandial levels were not
significantly altered. A study by Gurbuz et al in 2003 assessed the effects of betamethasone
on the one-hour glucola test and found that although there was an initial effect on the
screening test, this effect was transient and resolved generally one week after the
administration of the second dose of betamethasone. These patients had a one-hour screening
test performed prior to the administration of corticosteroids. The dosing regimen of
betamethasone, however, was different from that recommended by ACOG. Thus far, no study has
reported if: (1) there is significant hyperglycemia in non-diabetic patients who receive
corticosteroids and (2) how the magnitude and pattern of the increase in glucose differs in
patients with normal and abnormal one-hour glucolas or with diabetes. This study will be
conducted as a pilot study, as there is no reports of the extent of hyperglycemia that
occurs in non-diabetic patients after administration of corticosteroids to guide a sample
size calculation. We will plan to obtain thirty non-diabetic subjects with fifteen
diet-controlled diabetic controls for comparison. The hypothesis is that those patients that
are not diabetic will not have the same extent of hyperglycemia as those who are diabetic.

Inclusion criteria:

- Candidates for antenatal corticosteroids (including gestational age between 24-34
weeks)

Exclusion criteria:

- Age less than 18 years

- Pre-existing maternal corticosteroid or beta-mimetic tocolytic use

- Pre-gestational diabetes mellitus, class C or greater

- Pre-existing adrenal or pancreatic dysfunction

- Evidence of infection
We found this trial at
1
site
2801 Atlantic Ave
Long Beach, California 90806
(562) 933-5437
Miller Children's Hospital Miller Children
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from
Long Beach, CA
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