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治験 NCT05949008（対象：NIDDM、肥満）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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カリフォルニア大学ロサンゼルス校Effect of Metformin, a Drug Used to Treat Diabetes, vs Placebo
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05949008 は NIDDM、肥満 に関する 予防 の研究で、第IV相・第四段階 介入研究 臨床試験 です。現在は 実施中／登録終了 で、2023年11月22日 から開始しています。150 名の参加者 の募集が計画されています。この治験は カリフォルニア大学ロサンゼルス校 によって主催され、2027年7月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年5月7日 です。
概要
Metformin is a drug used to treat patients with diabetes. The aim of this study is to examine the effect of Metformin along with a low-calorie diet on obese and/or overweight adults with an increased waist measurement. In addition, the study also aims to look at the effect of the drug vs. placebo on quality of life and physical activity.
詳細説明
Obesity is a growing epidemic in the United States. Weight gain is associated with an increased risk of developing life-threatening conditions such as high blood pressure or diabetes. Therefore, there is great interest in developing non-invasive treatments to help combat obesity. Currently, there are only few weight-loss drugs available for the treatment of obesity. In the more recent past, GLP-1 analogues (a type of non-insulin medication used to treat patients with diabetes) are being promoted as a new strategy to lose weight without major side effects however, with high costs and challenging supply chain issues.
This is a double-blinded, randomized study. This means that participants will be assigned to one of two groups. Participants will have a 1:1 chance of being assigned to receive either the study drug or a placebo (a capsule that does not contain the active ingredients). This assignment will be determined by chance. The process is similar to drawing cards or picking straws. This means your assignment to one of the groups is based on chance and not a medical decision made by the study doctor. In addition, neither participants nor the investigators will know what groups participants have been assigned to.
During this study, your participation will last up to 26 weeks (including screen) with a total of 8 clinic visits. Participants will undergo a total of 5 blood draws, blood samples will be taken at screen baseline and weeks 8, 16 and 24.
公式タイトル
Effect of Metformin ER With Hypocaloric Diet on Weight Loss in Overweight/Obese Patients With Increased Waist Circumference
疾患／病気
NIDDM肥満その他の研究識別子
- 22-001670
NCT番号
開始日
2023-11-22
最終更新日
2025-05-07
終了予定日
2027-07-30
目標参加者数
150
試験の種類
介入研究
治験の相・段階
第IV相・第四段階
状況
実施中／登録終了
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Metformin Extended Release (ER) Oral Tablets This is a 24-week, randomized, double-blinded, two arm parallel clinical trial comparing metformin ER vs. placebo in combination with a hypocaloric diet (-500 kcal/day). 150 individuals with obesity and increased waist circumference will be randomized to taking metformin ER with hypocaloric diet or placebo with hypocaloric diet. All patients will receive dietary and exercise counseling with the intent of reducing their average caloric intake by 500 kcal/day. | Metformin Extended Release (ER) Oral Tablet Metformin ER will be provided as 1000 mg capsules by Qingdao Baheal Pharmaceutical Co., Ltd. In addition to the active ingredient metformin HCl,each tablet contains the following inactive ingredients: Povidone, Sodium Lauryl Sulfate, Magnesium Stearate, Cellulose Acetate, Polyethylene Glycol (PEG 400, PEG 8000), Triacetin, Hypromellose, Titanium Dioxide, Polysorbate 80, Ferrosoferric Oxide, Shellac. |
プラセボ対照薬Placebo Patients in the placebo arm will be randomized to placebo with hypocaloric diet. All patients will receive dietary and exercise counseling with the intent of reducing their average caloric intake by 500 kcal/day. | プラセボ Matching placebo will be provided as 1000 mg capsules |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Number of participants who achieve body weight reduction ≥5% from baseline | Percent change in body weight reduction ≥5% from baseline (week 0) to week 24. | 24 Weeks |
Change in total body weight from baseline | Percent change in total body weight (TBW) from baseline (week 0) to week 24 in body weight. | 24 Weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in total Body Mass Index (BMI) from baseline | Change from baseline (week 0) to week 24 in: BMI | 24 Weeks |
Percent change in body composition from baseline | Change from baseline (week 0) to week 24 - Body composition will be measured using a bioelectrical impedance analysis (BIA) scale. Measurements will include fat mass (kg), lean mass (kg), and body fat percentage. Data will be summarized as mean change from baseline to study endpoint for each group. | 24 weeks |
Change in waist circumference from baseline | Change from baseline (week 0) to week 24 in:Waist circumference (cm) | 24 weeks |
Change in insulin sensitivity from baseline | Insulin sensitivity will be assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin levels. QUICKI (Quantitative Insulin Sensitivity Check Index) will be calculated using fasting glucose and insulin. The outcome will be reported as the change in QUICKI from baseline to Week 24. | 24 Weeks |
Change in fasting blood lipids from baseline | Change from baseline (week 0) to week 24 in Fasting blood lipids | 24 Weeks |
Change in vascular function parameters (blood pressure and pulse wave velocity) | Vascular function will be assessed through two parameters:
Systolic and diastolic blood pressure (mmHg)
Pulse wave velocity (m/s) Each variable will be reported as a change from baseline to Week 24. | 24 weeks |
Change in inflammatory markers from baseline | 24 weeks | |
Change in daily dietary intake (calories and macronutrients) | Daily energy and macronutrient intake will be assessed using 3-day food records. The outcome includes:
Total energy intake (kcal/day) Carbohydrate intake (g/day) Protein intake (g/day) Fat intake (g/day) Each variable will be reported as a change from baseline to Week 24. | 24 weeks |
Change in physical activity levels from baseline | Physical activity will be tracked using MyFitnessPal, which syncs data from wearable devices and user-logged exercise sessions. The following variables will be assessed:
Average daily step count (steps/day) Weekly exercise duration (minutes/week), including structured physical activity Exercise frequency (days/week) | 24 weeks |
Change in quality of life from baseline | ● SF-36 QOL questionnaire | 24 weeks |
Change in glycemic control | Glycemic control will be assessed by measuring fasting glucose (mg/dL), fasting insulin (µIU/mL), and glycated hemoglobin A1c (reported as % and mmol/mol). All three measures will be obtained at baseline and Week 24. Each parameter will be reported as a change from baseline. | 24 weeks |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Male or female, age ≥ 18 years at the time of signing informed consent.
- Body Mass Index (BMI) ≥ 27 kg/m2
- Waist circumference >40" for men, and >35" for women
- A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- Diagnosed with T2D (HbA1c >7.5 (53 mmol/mol)
- Current use of insulin or oral medication of metformin, SU, SGLT2i, glitazone, DPP4 or GLP-1 agonist injections as single agent therapy or combination oral agents.
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 45 mL/min/1.73 m2 (< 60 ml/min/1.73 m2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 201242 by the central laboratory at screening
- History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months (History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable).
- History or lactic acidosis
- Liver problems
- Congestive heart failure
- History of alcoholism
- Recent surgery
- Heart attack, severe infection or stroke
- Any unstable medical conditions or terminal diagnosis
- Pregnancy or lactation
- Allergy and intolerance to metformin
カリフォルニア大学ロサンゼルス校340 件のアクティブな治験を探索責任者
Vijaya Surampudi MD, 研究責任者, Principal Investigator, University of California, Los Angeles
連絡先情報がありません。
1 1カ国の場所
California
UCLA Center for Human Nutrition, Los Angeles, California, 90024, United States