Trial Outcomes & Findings for Lipid Metabolism in Gestational Diabetes (NCT NCT00534105)

NCT ID: NCT00534105

Last Updated: 2013-09-11

Results Overview

Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls

• Recruitment status: COMPLETED
• Target enrollment: 106 participants
• Primary outcome timeframe: Postpartum
• Results posted on: 2013-09-11

Participant Flow

Pregnant patients presenting for gestational diabetes screening

Only uncomplicated obstetrical patients

Participant milestones

Measure	Gestational Diabetics Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.	Normal Pregnancies Normal pregnant women without gestational diabetes
Overall Study STARTED	47	59
Overall Study COMPLETED	24	20
Overall Study NOT COMPLETED	23	39

Reasons for withdrawal

Measure	Gestational Diabetics Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.	Normal Pregnancies Normal pregnant women without gestational diabetes
Overall Study Lost to Follow-up	23	39

Baseline Characteristics

Lipid Metabolism in Gestational Diabetes

Baseline characteristics by cohort

Measure	Gestational Diabetics n=47 Participants Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.	Normal Pregnancies n=59 Participants Normal pregnant women without gestational diabetes	Total n=106 Participants Total of all reporting groups
Age Continuous Age at Recruitment	32 years n=5 Participants	30 years n=7 Participants	31 years n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	59 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants	59 participants n=7 Participants	106 participants n=5 Participants

PRIMARY outcome

Timeframe: Postpartum

Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls

Outcome measures

Measure	Gestational Diabetics n=24 Participants Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.	Normal Pregnancies n=20 Participants Normal pregnant women without gestational diabetes
Cholesterol	204 mg/dl Interval 139.0 to 330.0	201 mg/dl Interval 169.0 to 228.0

SECONDARY outcome

Timeframe: Postpartum

Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.

Outcome measures

Measure	Gestational Diabetics n=24 Participants Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.	Normal Pregnancies n=20 Participants Normal pregnant women without gestational diabetes
Triglyceride Values	118 mg/dl Interval 74.0 to 174.0	83 mg/dl Interval 52.0 to 109.0

SECONDARY outcome

Timeframe: Postpartum

Triglyceride values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.

Outcome measures

Measure	Gestational Diabetics n=24 Participants Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.	Normal Pregnancies n=20 Participants Normal pregnant women without gestational diabetes
HDL	51 mg/dl Interval 41.0 to 57.0	57 mg/dl Interval 52.0 to 69.0

SECONDARY outcome

Timeframe: Postpartum

LDL values were obtained at least 6 weeks postpartum in both the gestational diabetic group and the normal controls.

Outcome measures

Measure	Gestational Diabetics n=24 Participants Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.	Normal Pregnancies n=20 Participants Normal pregnant women without gestational diabetes
LDL	124 mg/dl Interval 110.0 to 154.0	120 mg/dl Interval 83.0 to 150.0

Adverse Events

Gestational Diabetics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Pregnancies

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Glenn Markenson MD

Baystate Medical Center

Phone: 413-794-8073

Email: glenn.markenson@bhs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place