Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus
2020年7月22日 更新者：Women and Infants Hospital of Rhode Island
This study is a prospective, unmasked randomized clinical trial comparing the use of insulin vs combination insulin and metformin for treatment in women diagnosed with gestational diabetes mellitus (GDM).
The investigator's hypothesis is that the combination of metformin and insulin will be superior to insulin alone to achieve tight glucose control during pregnancy.
調査の概要
詳細な説明
The objective of this study is to compare the effectiveness of insulin alone vs the combination of insulin and metformin in treating patients with gestational diabetes (GDM).
Currently, outside of pregnancy, the treatment of type 2 diabetes mellitus (T2DM) with both metformin and insulin is superior to using insulin alone.
In pregnancy, insulin alone has traditionally been used, though some advocate the use of metformin alone as primary therapy.
There have been no trials published to date specifically comparing combination therapy to insulin alone.
Our hypothesis is that the combination of metformin and insulin will improve overall control of blood glucose, the improvement of which has been demonstrated to improve maternal and neonatal outcomes.
Control of blood glucose will be determined by hemoglobin A1c at the time of delivery.
研究の種類
介入
入学 (実際)
1
段階
- フェーズ 3
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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Rhode Island
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Providence、Rhode Island、アメリカ、02905
- Women & Infants Hospital
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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:
- Able to read and write English and/or Spanish and give written consent
- Diagnosis of GDM, defined as an abnormal glucose tolerance test performed after 12 weeks gestation using 1 of the 2 criteria below:
- 50 gram 1 hour oral diabetes screening testing yielding a result of > 200 mg/dL
- A 100 gram 3 hour oral glucose tolerance testing yielding >2 abnormal values (normal values defined as fasting blood glucose < 95, 1 hour < 180, 2 hour < 155 and 3 hour < 140)
- Singleton gestation
- Gestational age between 12 and 34 weeks and 6 days determined by last menstrual period (LMP) confirmed by ultrasound using criteria set forth by the ACOG (Committee on Obstetric Practice). If LMP is unknown then gestational age must be set by ultrasound prior to 20 weeks gestation.
Exclusion Criteria:
- Pre-existing DM either by diagnosis preceding pregnancy or hemoglobin A1c >6.5 collected during the current pregnancy
- Uncontrolled chronic hypertension, as this may alter maternal and perinatal outcomes measured.
- Multiple gestations
- Major fetal anomalies anticipated to require NICU admission
- Contraindication to metformin (allergy, history of lactic acidosis, pre-existing renal disease (Cr >1.5 mg/dL), active liver disease, current alcohol abuse).
- Vitamin B12 deficiency, as metformin reduces intestinal absorption of vitamin B12
- Medications known to effect glucose metabolism other than insulin and metformin as this may mask any effect between the two treatments.
- Known inability to tolerate metformin.
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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アクティブコンパレータ：インスリン
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Weight based insulin will be calculated using 0.7 units/kg/day in the first trimester, 0.8 units/kg/day in the second trimester and 1 units/kg/day in the third trimester.
This total insulin will then be divided into short acting insulin and intermediate acting insulin per provider discretion.
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アクティブコンパレータ：insulin and metformin
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Weight based insulin will be calculated using 0.7 units/kg/day in the first trimester, 0.8 units/kg/day in the second trimester and 1 units/kg/day in the third trimester.
This total insulin will then be divided into short acting insulin and intermediate acting insulin per provider discretion.
Will be initiated at dose of 500 mg twice daily.
If glycemic control is suboptimal, the dose of metformin will be increased to 1000 mg twice a day.
Metformin will be titrated prior to increases in insulin.
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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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Hgb A1c
時間枠：collected at the time of delivery
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Hgb A1c test
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collected at the time of 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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Total daily dose of insulin
時間枠：Will be recorded on hospital admission for delivery
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Total daily dose of insulin at the end of pregnancy
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Will be recorded on hospital admission for delivery
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Glucose control
時間枠：patients will collect glucose values fasting and 2 hrs postprandial every day from enrollment until delivery.
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Average of fasting and 2 hour postprandial glucose values
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patients will collect glucose values fasting and 2 hrs postprandial every day from enrollment until delivery.
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Incidence of maternal hypoglycemia
時間枠：patients will be screened weekly for episodes of hypoglycemia until delivery
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episodes of maternal hypoglycemia defined as glucose ≤70 mg/dL
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patients will be screened weekly for episodes of hypoglycemia until delivery
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Change in hemoglobin A1c over the course of the pregnancy
時間枠：hemoglobin A1c will be collected at delivery (per above) and comparison performed after collection
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If baseline hemoglobin A1c was collected as part of routine care prior to enrollment, this value will be compared to the hemoglobin A1c collected at delivery
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hemoglobin A1c will be collected at delivery (per above) and comparison performed after collection
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Incidence of maternal side effects
時間枠：Will be assessed weekly until delivery
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maternal reported medication side effects (i.e.
nausea, vomiting, diarrhea)
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Will be assessed weekly until delivery
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Treatment acceptability
時間枠：Will be collected postpartum after delivery
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determined using Diabetes Treatment Satisfaction Questionnaire.
Survey includes 8 questions that are answered on a scale of 0-6; 0 indicating the least and 6 the highest level of satisfaction.
The individual questions will be compared.
Total satisfaction will also be compared by summing the responses to all 8 questions on a composite scale of 0-48
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Will be collected postpartum after delivery
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Maternal weight gain
時間枠：This will be calculated as the difference from the weight measured at the inital prenatal visit (the specific timing of which is patient dependant) and at the time of admission for delivery
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weight gain through pregnancy
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This will be calculated as the difference from the weight measured at the inital prenatal visit (the specific timing of which is patient dependant) and at the time of admission for delivery
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Incidence of hypertensive disorder of pregnancy
時間枠：from enrollment through study completion (30 days after delivery)
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gestational HTN, superimposed pre-eclampsia, pre-eclampsia-eclampsia
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from enrollment through study completion (30 days after delivery)
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Incidence of composite of adverse maternal outcomes
時間枠：from enrollment through study completion (30 days after delivery)
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death, ICU admission, postpartum hemorrhage, blood transfusion, organ failure, chorioamnionitis/endometritis
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from enrollment through study completion (30 days after delivery)
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Breast feeding status
時間枠：Will be recorded at the time of hospital discharge after delivery (typically 2-4 days after delivery)
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Whether patient is breast feeding or bottle feeding upon discharge from the hospital after delivery
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Will be recorded at the time of hospital discharge after delivery (typically 2-4 days after delivery)
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Mode of delivery
時間枠：recorded at time of delivery
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Mode of delivery
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recorded at time of delivery
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Gestational age at delivery
時間枠：recorded at time of delivery
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Gestational age at delivery
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recorded at time of delivery
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Infant birthweight (using age/sex matched percentiles)
時間枠：measured at time of birth
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Infant birthweight (using age/sex matched percentiles)
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measured at time of birth
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Incidence of composite neonatal morbidity
時間枠：from delivery through study completion (30 days after delivery)
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Presence of any of the following: NICU admission, hypoglycemia, hyperbilirubinemia, birth trauma, stillbirth, respiratory distress syndrome, sepsis, neonatal death prior to discharge, 5 minute Apgar score < 7, umbilical artery cord pH <7.10
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from delivery through study completion (30 days after delivery)
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Incidence neonatal hypoglycemia
時間枠：from delivery through study completion (30 days after delivery)
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hypoglycemia requiring intravenous treatment
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from delivery through study completion (30 days after delivery)
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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：Christopher Nau, MD、Women & Infants Hospital
- 主任研究者：Erika Werner、Women & Infants Hospital
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 (実際)
2018年1月3日
一次修了 (実際)
2019年7月30日
研究の完了 (実際)
2019年7月30日
試験登録日
最初に提出
2018年6月12日
QC基準を満たした最初の提出物
2018年8月27日
最初の投稿 (実際)
2018年8月29日
学習記録の更新
投稿された最後の更新 (実際)
2020年7月24日
QC基準を満たした最後の更新が送信されました
2020年7月22日
最終確認日
2020年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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