7-Ketolithocholic Acid in Prediabetes
A Multicentre, Double Blind, Placebo Controlled, Clinical Trial to Investigate the Effects and Tolerability of 7-Ketolithocholic Acid, a Novel Food, Associated to Diet and Physical Activity, in Lowering Fasting Plasma Glucose (FPG) Levels in Subjects With Pre-diabetes.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Dr. Riccardo Agati
- 電話番号：+33 (0)184636817
- メール：riccardo.agati@gmail.com
研究場所
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Bordighera、イタリア、18012
- 募集
- Studio Medico, Piazza Eroi della Libertà, 7
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コンタクト：
- Dr. Germano Mondino
- 電話番号：+33 018426921
- メール：g.mondino@alice.it
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Ospedaletti、イタリア、18014
- 募集
- Studio Medico, Via Roma, 46
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コンタクト：
- Dr. Fabrizia Lanzoni
- 電話番号：+33 3923689757
- メール：f.lanzoni@outlook.com
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San Bartolomeo al Mare、イタリア、18016
- 募集
- Studio Medico, Via Elba 21
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コンタクト：
- Dr. Ettore Perreca
- 電話番号：+33 0183409452
- メール：ettore.perreca@icloud.com
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Sanremo、イタリア、18038
- 募集
- Studio Medico, Corso Imperatrice 5
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コンタクト：
- Dr. Leandro Faraldi
- 電話番号：+33 3383604828
- メール：medicaleo@libero.it
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Sanremo、イタリア、18038
- 募集
- Studio Medico, Corso Matuzia 13
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コンタクト：
- Dr. Francesca Viale
- 電話番号：+33 366 4947040
- メール：dott.vialefrancesca@gmail.com
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Sanremo、イタリア、18038
- 募集
- Studio Medico, Via Galileo Galilei 475
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コンタクト：
- Dr. Nicolò Moraglia
- 電話番号：+33 3404034229
- メール：n.moraglia@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Male and female participants aged ≥18 years and ≤70 years.
- Ability and willingness to provide written informed consent.
Diagnosis of prediabetes, defined by the following metabolic criteria:
- Impaired fasting glucose (IFG): fasting plasma glucose levels between 100 and 125 mg/dL.
- Impaired glucose tolerance (IGT): plasma glucose levels between 140 and 199 mg/dL measured 2 hours after a standard oral glucose tolerance test (OGTT).
- Elevated HbA1c: HbA1c values between 5.7% and 6.4% (or 42 and 47 mmol/mol).
- Body mass index (BMI) in the range 25-31 kg/m2 (inclusive).
- Willingness to strictly comply with a low-glycaemic, hypocaloric diet during the study period and maintain a food diary.
- Willingness to comply with recommended physical activity during the study period and maintain an activity diary.
- Women of childbearing potential must agree to not become pregnant during the study and to use effective contraception (according to Recommendations related to contraception and pregnancy testing in clinical trials.
Exclusion Criteria:
- Previous or current diagnosis of diabetes mellitus.
- Presence of hypertension, defined as blood pressure >130/85 mmHg.
- Hypertriglyceridemia, defined as fasting blood triglyceride levels ≥ 200 mg/dL.
- LDL cholesterol ≥ 190 mg/dL.
- Current treatment with oral hypoglycaemic agents or use of supplements with hypoglycaemic effects.
- Use of any medication (self-medication or prescription medication) or supplementation potentially acting on glucose and lipid parameters within 28 days before entry in the study (or at least 5 times the respective elimination half-life, whichever is longer).
- Any medical condition or treatment that, in the opinion of the investigator, could interfere with the study outcomes or participant safety.
- Use of vitamin K antagonist anticoagulant drugs (such as warfarin).
- Pregnancy or breast-feeding.
- Any other condition that would preclude adherence to the study protocol or informed consent process, including, but not limited, to active or uncontrolled metabolic, endocrine, cardiovascular, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, or psychiatric disease.
- Subjects with any history of hypersensitivity to the product under study or its excipients (please refer to Appendix B for listing of ingredients).
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
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：7-KLCA
Coated tablets containing 400 mg of 7-Ketolithocholic Acid, taken once daily in tablet form.
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This is a prospective, randomized, double blind, multicenter study. Subjects will be randomized in a 1:1 ratio; each subject will be included into one of the two intervention groups. Each subject will attend 6 visits in total Visit 1: Day -7 (Screening, Informed consent signature, sampling for laboratory tests) Visit 2: Day 0 (Eligibility assessment, enrolment, randomization, drug dispense; diary dispense) Visit 3: Week +4 (Telephone call, diary verification) Visit 4: Week +8 (same as Visit 3) Visit 5: Week +12 (sampling for laboratory tests like Visit 1. Diary verification. End of treatment) Visit 6: Week +16 (End of Study, EOS. Same as visit 5, excluding OGTT) The onset of Adverse Events and the use of Concomitant Medications will be verified and, if necessary, recorded at every visit. Both groups will undergo a low-glycaemic, hypocaloric diet, and recommended physical activity. The dietary intervention in this study involves a low-glycaemic, hypocaloric diet, aimed at improving glycaemic control, reducing fasting plasma glucose, and supporting weight management, based on official recommendations from authoritative bodies such as the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Physical activity is a cornerstone of lifestyle intervention in prediabetes. It improves insulin sensitivity, glucose metabolism, and cardiovascular risk factors, and facilitates weight management [2,24]. Combining physical activity with dietary modifications enhances prevention of progression to type 2 diabetes. All of the following will be recommended: aerobic exercise, resistance training, reducing sedentary time, flexibility and balance exercises. |
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プラセボコンパレーター：Placebo
Placebo tablets with the same aspect and composition of active comparator but not containing any active ingredient (no 7-KLCA), taken once daily in tablet form.
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The dietary intervention in this study involves a low-glycaemic, hypocaloric diet, aimed at improving glycaemic control, reducing fasting plasma glucose, and supporting weight management, based on official recommendations from authoritative bodies such as the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Physical activity is a cornerstone of lifestyle intervention in prediabetes. It improves insulin sensitivity, glucose metabolism, and cardiovascular risk factors, and facilitates weight management [2,24]. Combining physical activity with dietary modifications enhances prevention of progression to type 2 diabetes. All of the following will be recommended: aerobic exercise, resistance training, reducing sedentary time, flexibility and balance exercises. This is a prospective, randomized, double blind, multicenter study. Subjects will be randomized in a 1:1 ratio; each subject will be included into one of the two intervention groups. Each subject will attend 6 visits in total Visit 1: Day -7 (Screening, Informed consent signature, sampling for laboratory tests) Visit 2: Day 0 (Eligibility assessment, enrolment, randomization, drug dispense; diary dispense) Visit 3: Week +4 (Telephone call, diary verification) Visit 4: Week +8 (same as Visit 3) Visit 5: Week +12 (sampling for laboratory tests like Visit 1. Diary verification. End of treatment) Visit 6: Week +16 (End of Study, EOS. Same as visit 5, excluding OGTT) The onset of Adverse Events and the use of Concomitant Medications will be verified and, if necessary, recorded at every visit. Both groups will undergo a low-glycaemic, hypocaloric diet, and recommended physical activity. |
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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Mean change in Fasting Plasma Glucose (FPG)
時間枠：Baseline and Week 12
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Difference in the mean change in fasting plasma glucose (FPG) from baseline to Week 12 between the treatment and placebo groups.
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Baseline and Week 12
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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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Difference in mean changes in HbA1c, cholesterol, LDL, HDL, body weight and/or BMI, waist circumference, 2 hr oral glucose tolerance test.
時間枠：Baseline and Week 12
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To observe the effects of 7-Ketolithocholic Acid associated with diet and physical activity on glycaemic metabolism, lipid profile and BMI/waist circumference.
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Baseline and Week 12
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Assessment of overall safety and tolerability of 7-KLCA (400mg) administered for 12 weeks.
時間枠：Throughout the course of the study period (12 weeks).
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Number and description of Adverse Events and Serious Adverse Events (including laboratory changes) in the two groups of treatment (7-Ketolithocholic Acid 400 mg and placebo administered for 12 weeks).
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Throughout the course of the study period (12 weeks).
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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
- 7Keto-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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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