Impact of Meal Composition and Alcohol Consumption on Postprandial Glycemic Control in Subjects With Type 1 Diabetes
Evaluación Del Impacto de la composición Nutricional de la Ingesta y Del Consumo de Alcohol en el Control glucémico Postprandial en Pacientes Con Diabetes Tipo 1
Postprandial glucose control is a challenging issue in everyday diabetes care. Indeed, excessive postprandial glucose excursions are the major contributors to plasma glucose (PG) variability in subjects with type 1 diabetes (T1DM). In addition, the poor reproducibility of postprandial glucose response is burdensome for patients and healthcare professionals.
To date, the majority of prandial insulin dosing algorithms for subjects with T1DM considers only the carbohydrate (CHO) content of the meal. However, there is evidence (although with a certain degree of heterogeneity) that meal composition significantly affects postprandial glucose control, contributing to glycemic variability. Moreover, despite the high prevalence of alcohol consumption among patients with T1DM (about 30%, similar to that of the general population), data regarding its effect on the postprandial period are very limited.
This project will evaluate the effect of meal composition and alcohol consumption on postprandial glucose control in subjects with T1DM under intensive insulin treatment.
調査の概要
詳細な説明
Randomized, prospective, single-centre (Hospital Francesc de Borja, Gandia, Spain), single-blind (analysis), three -way, crossover study on type 1 diabetic subjects (n=12) under intensive insulin treatment.
Aim:
To assess the effect of mixed meal composition on postprandial glycemic control, in subjects with type 1 diabetes:
- Combined effect of proteins and fats
- Effect of alcohol consumption
Methods:
Each subject will undergo three mixed meal test studies (on three different days), with identical CHO content: On one occasion a low fat-low protein meal will be given, and on another a high fat-high protein one, both consumed with a non-alcoholic drink; on a third occasion the same high fat-high protein meal will be consumed, but this time accompanied by an equal volume of an alcoholic drink.
Patients will arrive at the research unit at 8:00 am and their blood glucose will be stabilized around 90 mg/dl before each mixed meal test. After the mixed meal, blood will be drawn every 5-30 min during a 6 hour post-prandial period to assess plasma glucose, hormones and metabolites concentration.
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
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-
Valencia
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Gandia、Valencia、スペイン、46072
- Hospital Francesc de Borja
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-
参加基準
適格基準
就学可能な年齢
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:
Patients with type 1 diabetes mellitus for more than one year, aged between 18 and 60 years; on intensive insulin therapy by means of CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for at least 6 months before screening; glycosylated haemoglobin of 6-8.5%; without severe chronic micro- and macroangiopathic diabetic complications and with a body mass index (BMI) between 18 and 30 kg/m2.
Exclusion Criteria:
- Pregnancy and lactation
- Hypoglycemia unawareness
- Fatal or progressive disease
- Drugs or alcohol abuse
- HIV, active hepatitis B, active hepatitis C
- Hepatic disease (aminotransferases AST or ALT >2 times above normal)
- Clinically relevant microangiopathic disease, or other diseases that may interfere with participation in the study or data analysis
- Pre-planned surgery
- Blood donation in the previous 3 months for men and 6 months for women
- Mental conditions that may interfere with the subject's comprehension of the aims and possible consequences of the study
- Non-compliant subjects
- Use of experimental medications or devices during the previous 30 days
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：他の
- 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 Protein-Low Fat study
Subjects will receive a mixed meal with carbohydrates (70g) plus a low content of proteins and fats
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A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given
|
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実験的：High Protein-High Fat study
Subjects will receive a mixed meal with the same carbohydrates content of arm 1 (70g), but a greater amount of fats and proteins
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A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given
|
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実験的：High Protein-High Fat & alcohol study
Subjects will receive the same mixed meal of the High Protein-High Fat study plus 0,7g of alcohol per Kg of weight
|
A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given
|
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 |
|---|---|---|
|
Plasma Glucose
時間枠：6 hours (plasma glucose will be measured every 5-15 minutes during the 6-hour post-prandial period of each mixed meal test).
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Post-prandial plasma glucose time series
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6 hours (plasma glucose will be measured every 5-15 minutes during the 6-hour post-prandial period of each mixed meal test).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
AUC-PG
時間枠：AUC of plasma glucose will be calculated for the whole 6 hour post-prandial period, for the early 0-3 hour post-prandial period and for the late 3-6 hour post-prandial period.
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Area Under the Curve (AUC) of Plasma Glucose in the 0-6h, 0-3h and 3-6h post-prandial periods
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AUC of plasma glucose will be calculated for the whole 6 hour post-prandial period, for the early 0-3 hour post-prandial period and for the late 3-6 hour post-prandial period.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time in range
時間枠：6 hours (time in range during the 6 hour post-prandial period)
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Time in acceptable glucose range (70-180 mg/dl)
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6 hours (time in range during the 6 hour post-prandial period)
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C Max
時間枠：6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period)
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Maximum of plasma glucose concentration
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6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period)
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T max
時間枠：6 hours (Time of maximum plasma glucose concentration during the 6 hour post-prandial period)
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Time of Maximum plasma glucose concentration
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6 hours (Time of maximum plasma glucose concentration during the 6 hour post-prandial period)
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Hormones and metabolites
時間枠：6 hours (plasma hormones and metabolites will be measured every 30 minutes during the 6-hour post-prandial period)
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Plasma concentration of free fatty acids, beta-OH-butyrate, lactate, alanine, counterregulatory hormones
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6 hours (plasma hormones and metabolites will be measured every 30 minutes during the 6-hour post-prandial period)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Paolo Rossetti, PhD、Hospital Francesc de Borja, Gandia
- スタディディレクター：Jorge Bondia Company, PhD、Universitat Politécnica de Valéncia
出版物と役立つリンク
一般刊行物
- Bell KJ, Smart CE, Steil GM, Brand-Miller JC, King B, Wolpert HA. Impact of fat, protein, and glycemic index on postprandial glucose control in type 1 diabetes: implications for intensive diabetes management in the continuous glucose monitoring era. Diabetes Care. 2015 Jun;38(6):1008-15. doi: 10.2337/dc15-0100.
- Bell KJ, Toschi E, Steil GM, Wolpert HA. Optimized Mealtime Insulin Dosing for Fat and Protein in Type 1 Diabetes: Application of a Model-Based Approach to Derive Insulin Doses for Open-Loop Diabetes Management. Diabetes Care. 2016 Sep;39(9):1631-4. doi: 10.2337/dc15-2855. Epub 2016 Jul 7.
- Barnard K, Sinclair JM, Lawton J, Young AJ, Holt RI. Alcohol-associated risks for young adults with Type 1 diabetes: a narrative review. Diabet Med. 2012 Apr;29(4):434-40. doi: 10.1111/j.1464-5491.2012.03579.x.
- Turner BC, Jenkins E, Kerr D, Sherwin RS, Cavan DA. The effect of evening alcohol consumption on next-morning glucose control in type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1888-93. doi: 10.2337/diacare.24.11.1888.
- Kerr D, Cheyne E, Thomas P, Sherwin R. Influence of acute alcohol ingestion on the hormonal responses to modest hypoglycaemia in patients with Type 1 diabetes. Diabet Med. 2007 Mar;24(3):312-6. doi: 10.1111/j.1464-5491.2006.02054.x.
- Garcia A, Moscardo V, Ramos-Prol A, Diaz J, Boronat M, Bondia J, Rossetti P. Effect of meal composition and alcohol consumption on postprandial glucose concentration in subjects with type 1 diabetes: a randomized crossover trial. BMJ Open Diabetes Res Care. 2021 Oct;9(1):e002399. doi: 10.1136/bmjdrc-2021-002399.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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。
1型糖尿病の臨床試験
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