Continuous Glucose Monitoring to Measure Effect of Glycemic Index
The Effect of Glycemic Index on Post-prandial Glycemia (Breakfast vs. Lunch) in Patients With Type 1 Diabetes: Quantification With Continuous Glucose Monitoring
Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.
Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring.
Design: Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low GI; in the other, high GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat content. Each subject received his usual pre-prandial insulin dosage, followed by a continuous subcutaneous basal insulin infusion for the remainder of the experiment. Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded every 5 minutes.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Oregon
-
Portland、Oregon、アメリカ、97232
- Legacy Health System--Holladay Park Campus
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- clinical diagnosis of type 1 diabetes mellitus
- patients on insulin pump therapy
Exclusion Criteria:Any patient who was
- pregnancy
- cardiovascular, cerebrovascular, kidney, or liver disease
- uncontrolled chronic medical conditions
- oral or parenteral corticosteroid use
- immunosuppressant use
- visual or physical impairments that impede the use of a continuous glucose monitoring device
- insulin or glucagon allergy
- hypoglycemia unawareness
- requirement of greater than 200 units of insulin per day
- gastroparesis
- any prior gastric surgery
- an allergy to any food items served.
研究計画
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：支持療法
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：low glycemic index effect on post-prandial peak
Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each.
In one experiment, both meals had a low Glycemic Index.
|
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
|
|
アクティブコンパレータ：high glycemic index effect on post-prandial peak
Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each.
In one experiment, both meals had a high Glycemic Index.
|
A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
|
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 |
|---|---|---|
|
Mean Area Under the Curve for Rise in Breakfast Post-prandial.
時間枠：Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast
|
Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals.
Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.
|
Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：W K Ward, MD、Legacy Health System
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。