Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes (MIPOD)
2017年4月21日 更新者：University of North Carolina, Chapel Hill
Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)
Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy.
Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.
調査の概要
研究の種類
介入
入学 (実際)
31
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina Hospitals Obstetric Clinics
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital
- Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
- Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria
- Less than 24 weeks at study enrollment
- Singleton or twin pregnancy
- English or Spanish speaking
- Able to give informed consent
Exclusion Criteria:
- End organ complications of diabetes (retinopathy, renal insufficiency, etc.)
- Prior need for insulin for glycemic control
- History of diabetic ketoacidosis (DKA) or hyperosmolar state
- Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin
- Kidney or liver disease
- Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Metformin
Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation.
After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group.
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Women randomized to the Experimental arm will receive standard diet and glucose self-monitoring education.
They will be initiated on Metformin 500 BID if they were medication naïve, or will be continued on their current dosage of Metformin if they were taking it prior to pregnancy.
At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to a maximum of 2250mg/day to achieve target glycemic control.
If glycemic control can not be achieved with Metformin as a single agent insulin will be added.
他の名前：
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アクティブコンパレータ：Insulin
Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation.
After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group.
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Women randomized to the Insulin group will receive standard diet and glycemic monitoring education.
They will be initiated on weight based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular)administered with dinner.
At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Blood Glucose Measurements
時間枠：Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery
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Patients self monitored glucose measures throughout pregnancy to aid glycemic control.
Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.
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Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Number of Patients With Obstetric Complications
時間枠：Throughout pregnancy until hospital discharge following delivery.
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Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.
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Throughout pregnancy until hospital discharge following delivery.
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Maternal Weight Gain
時間枠：Baseline throughout pregnancy until last prenatal visit.
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Baseline throughout pregnancy until last prenatal visit.
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Number of Babies With Neonatal Hypoglycemia
時間枠：Time of delivery through hospital discharge
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Initial neonatal glucose < 40 mg/dL
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Time of delivery through hospital discharge
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Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester
時間枠：1st, 2nd, and 3rd trimester
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1st, 2nd, and 3rd trimester
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Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)
時間枠：Baseline throughout pregnancy until time of delivery
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NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES <95
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Baseline throughout pregnancy until time of delivery
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Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)
時間枠：Baseline throughout pregnancy until time of delivery
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NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES <130
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Baseline throughout pregnancy until time of delivery
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Number of Episodes Maternal Hypoglycemia
時間枠：Baseline throughout pregnancy until time of delivery
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Maternal glucose < 60 mg/dL
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Baseline throughout pregnancy until time of delivery
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Number of Babies With Adverse Neonatal Outcomes
時間枠：Delivery until hospital discharge
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Resuscitation in the delivery room, preterm birth < 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy.
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Delivery until hospital discharge
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Ashley Hickman, MD、University of North Carolina, Chapel Hill
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年8月1日
一次修了 (実際)
2010年2月1日
研究の完了 (実際)
2010年4月1日
試験登録日
最初に提出
2009年2月2日
QC基準を満たした最初の提出物
2009年2月2日
最初の投稿 (見積もり)
2009年2月4日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月25日
QC基準を満たした最後の更新が送信されました
2017年4月21日
最終確認日
2014年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- UNC08-0898
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