The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes (RaSlo-19)
2020年6月24日 更新者:Steno Diabetes Center Copenhagen
In the effort of better understanding the glucose control in people with type 1 diabetes, in-depth insight into the physiology of hepatic glucose production and its influencing factors is essential.
Previously, a number of potential influencing factors of hepatic glucose production have been investigated, including insulin-on-board, low carbohydrate diet, preceding ethanol intake, exercise and multiple stimulations of hepatic glucose production.
Previous post-hoc analysis of dual-hormone closed-loop systems has indicated that the rate of fall in blood glucose influences the following stimulation of hepatic glucose response.
However, the rate of fall in blood glucose is highly related to insulin levels, which may explain those findings.
Thus, in this study the investigators want to examine whether the different rates of fall in blood glucose with similar insulin levels on board affect the hepatic glucose response in individuals with type 1 diabetes.
In the study, which will be conducted at Steno Diabetes Center Copenhagen, participants will complete two study visits.
On each visit, a hypoglycemic clamp technique will be used to lower the blood glucose levels of the participants (using either a rapid or slow decline rate), whereupon hepatic glucose production will be stimulated using low-dose glucagon.
The study days are divided into four phases: 1) preparation phase, 2) hyperinsulinemic euglycemic phase (stabilization of blood glucose), 3) hyperinsulinemic hypoglycemic phase (rapid or slow decline in blood glucose) and 4) post-glucagon administration phase.
This design will allow the investigators to examine whether differences in hepatic glucose response exist depending on preceding rate of fall in blood glucose.
We hypothesize that the rate of fall in blood glucose does not affect the hepatic glucose production.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
10
段階
- 適用できない
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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Gentofte、デンマーク、2820
- Steno Diabetes Center Copenhagen
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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~70年 (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
全て
説明
Inclusion Criteria:
- Age 18-70 years
- Duration of Type 1 Diabetes ≥ 3 years
- Insulin pump use > 6 months
Exclusion Criteria:
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- Allergy or intolerance to lactose or GlucaGen (Novo Nordisk, Bagsværd, DK)
- Use of medications that are known to cause QT interval prolongation
- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Females who have different basal insulin pattern depending on their menstrual cycle
- Inability to understand the individual information and to give informed consent
- Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation
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:基礎科学
- 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 |
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実験的:Rapid-Slow
This arm will begin with intervention "rapid" (rapid rate of fall in plasma glucose) for the first study visit and proceed to intervention "slow" (slow rate of fall in plasma glucose) for the second study visit.
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Rapid lowering of plasma glucose using hypoglycemic clamp technique
Slow lowering of plasma glucose using hypoglycemic clamp technique
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実験的:Slow-Rapid
This arm will begin with intervention "slow" (slow rate of fall in plasma glucose) for the first study visit and proceed to intervention "rapid" (rapid rate of fall in plasma glucose) for the second study visit.
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Rapid lowering of plasma glucose using hypoglycemic clamp technique
Slow lowering of plasma glucose using hypoglycemic clamp technique
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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 |
時間枠 |
---|---|
Positive incremental area under the glucose curve (PI-AUC) (using the plasma glucose concentration before glucagon administration as basal level)
時間枠:from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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二次結果の測定
結果測定 |
時間枠 |
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Total area under the glucose curve (AUC)
時間枠:from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Peak plasma glucose
時間枠:from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Incremental plasma glucose peak
時間枠:from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Time-to-peak plasma glucose
時間枠:from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Plasma glucose level
時間枠:120 minutes after glucagon administration
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120 minutes after glucagon administration
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Duration of plasma glucose above 4.0 mmol/l
時間枠:from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of plasma glucose above baseline
時間枠:from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Number of subjects who, after reaching a plasma glucose value > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-10 mmol/l
時間枠:throughout phase 4 (until 120 minutes after glucagon administration)
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throughout phase 4 (until 120 minutes after glucagon administration)
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Number of subjects who, after reaching a PG > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-7.8 mmol/l
時間枠:throughout phase 4 (until 120 minutes after glucagon administration)
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throughout phase 4 (until 120 minutes after glucagon administration)
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Time from glucagon administration to reaching a plasma glucose level > 3,9 mmol/l
時間枠:from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of a plasma glucose level in the range of 3.9-10 mmol/l
時間枠:from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of a plasma glucose level in the range of 3.9-7.8 mmol/l
時間枠:from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Change in insulin levels (measured as area under the curve)
時間枠:0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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Change in insulin levels (measured as peak change)
時間枠:from baseline to 120 minutes after glucagon administration
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from baseline to 120 minutes after glucagon administration
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Change in glucagon levels (measured as area under the curve)
時間枠:0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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Change in glucagon levels (measured as peak change)
時間枠:0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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Average changes in Edinburgh Hypoglycemia Scale
時間枠:measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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Average change in visual analogue scale score for nausea, headache, stomach ache and palpitations
時間枠:measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
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Number of subjects experiencing vomiting
時間枠:from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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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。
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)
2019年9月12日
一次修了 (実際)
2020年1月15日
研究の完了 (実際)
2020年1月15日
試験登録日
最初に提出
2019年9月11日
QC基準を満たした最初の提出物
2019年9月20日
最初の投稿 (実際)
2019年9月23日
学習記録の更新
投稿された最後の更新 (実際)
2020年6月25日
QC基準を満たした最後の更新が送信されました
2020年6月24日
最終確認日
2020年6月1日
詳しくは
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