Comparative the Effect of Metformin and Acupuncture on Weight Loss and Insulin Sensitivity
2016年10月14日 更新者：Amir Firouzjaei
Placebo-controlled, Randomized, Double Blind Trial, What is the Therapeutic Effect of Metformin and Acupuncture Combined Therapy in Comparison With Metformin Monotherapy on Weight Loss and Insulin Sensitivity in Diabetic Patients
The investigators designed this randomized double blind (patients/ assessor) clinical trial to compare the therapeutic effects of Metformin monotherapy with Metformin and acupuncture combined therapy on weight loss and insulin sensitivity among overweight/obese type 2 diabetes mellitus (T2DM) patients.
We compared the inflammatory markers, lipid profiles, and adipokines in overweight/obese T2DM patients receiving the combined therapy to those receiving the Metformin monotherapy, to understand whether acupuncture plus Metformin is a better approach then Metformin only on treating diabetes.
調査の概要
詳細な説明
From 39 participants, 19 participants were sent to case group and 20 to control group according to above mentioned method of randomization by independent research assistant.
In the case group enrolled participants were treated with Metformin monotherapy and received electro acupuncture (EA) and Auricular acupuncture at the selected acupoints, and participants in a control group were treated with Metformin monotherapy and received sham EA.
All patients were blinded to treatment assignment during the period of study and assessor was blinded to name of the patients and results as well.
IR was calculated by the homeostasis model assessment of insulin resistance (HOMA-IR) proposed by Matthews et al.
HOMA-IR = (fasting insulin (mmol/L) × fasting glucose (µIU/ml))/22.5;
body height was measured to an accuracy of +/-0.1cm;
body weight was measured while the subjects were dressed in light clothing after an overnight fasting by standard scale to an accuracy of +/-0.1 kg; The body mass index (BMI) was calculated by dividing weight (kg) into height (squared m²).
Blood markers including fasting blood sugar (FBS), fasting insulin (FINS), interleukin-6 (IL-6), tumor necrosis α (TNFα), C reactive protein (CRP), leptin, adiponectin, resistin, glucagon-like peptide-1 (GLP-1), HOMA index , free fatty acid (FFAs), low density lipoprotein cholesterol (LDLc), high density lipoprotein cholesterol (HDLc) , and ceramides; were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient after 8 hours overnight fasting, before treatment, and for FBS, FINS and HOMA index 30 min after treatment additionally, 3 times during the study (in the beginning, in the 5th time and at the end) from both groups, with the chosen for this research standard range.
All data with standard range were managed by Epi-data software, then analyzed by Statistical Package for the Social Sciences (SPSS) software 15.0.0 (6 Sep 2006).
The investigators statistics method included T-test and repeated measures ANOVA.
P-Value<0.05
was statistically significant in this trial
研究の種類
介入
入学 (実際)
43
段階
- 適用できない
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
20年～65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:
- Who had been diagnosed with type 2 diabetes mellitus and has using Metformin monotherapy as well to control their diabetes during the period of this study as previously (500 mg one/two/three times per day)
- All patients were overweight according to BMI ≥25
Exclusion Criteria:
- Individuals with nephritic syndrome (urine protein over 3.5 g/day), edema or renal failure (serum creatinine over 115 µmol/L)
- Individuals who had been diagnosed with heart failure (NYHA Fc III-IV) or who had been a pacemaker implanted
- Individuals with abnormal liver dysfunction (GOT and glutamate-pyruvate transaminase (GPT) levels twofold above the normal range) or a diagnosis of liver cirrhosis
- Individuals with a high HbA1C level (HbA1C above 9 %)
- Pregnant women
- Individuals who were receiving insulin therapy already
- Individuals who receive other therapy or had any change at dosage during the period of therapy
- Individuals who were suffering from endocrine abnormalities such as Thyroid disease, polycystic ovary syndrome (PCOS), etc
- Individuals who were receiving weight loss medicine, anti depressant agents' or hormonal medicines during the last 3 months and the period of study
- Individuals who were suffering from a homeostasis disorder or other systemic disease
- Individuals who did not comply(signed informed consent) with the treatment during the study period
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：metformin & acupuncture
Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.
|
metformin tablet 500 mg
Electro body acupuncture and auricular acupuncture
|
|
プラセボコンパレーター：metformin & placebo
Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time.
For ear acupuncture was just used sticky layers without seeds.
All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.
|
metformin tablet 500 mg
|
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 |
|---|---|---|
|
Body Weight
時間枠：baseline, week 3
|
The effect of Metformin and acupuncture combined therapy on weight loss (Change from baseline in body weight), body weight was measured while the subjects were dressed in light clothing after an overnight fasting and by a standard scale to an accuracy of +/-0.1 kg.
All measures were recorded by one assessment, at baseline before the first time treatment, and before the last time treatment at week 3.
|
baseline, week 3
|
|
Fasting Blood Sugar (FBS)
時間枠：baseline, week 2, week 3
|
changes FBS, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Fasting Insulin (FINS)
時間枠：baseline, week 2, week 3
|
change of FINS,Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Interleukin-6 (IL-6)
時間枠：baseline, week 2, week 3
|
IL-6 changes, IL-6 were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Tumor Necrosis Factor-α (TNF-α)
時間枠：baseline, week 2, week 3
|
Blood markers changes in TNF α, were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
C-reaction Protein (CRP)
時間枠：baseline, week 2, week 3
|
CRP blood markers changes; Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Free Fatty Acids (FFAs)
時間枠：baseline, week 2, week 3
|
Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Triglyceride (TG)
時間枠：baseline, week 2, week 3
|
baseline, week 2, week 3
|
|
|
Low Density Lipoprotein Cholesterol (LDLc)
時間枠：baseline, week 2, week 3
|
baseline, week 2, week 3
|
|
|
High Density Lipoprotein Cholesterol (HDLc)
時間枠：baseline, week 2, week 3
|
HDLc changes, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Ceramides
時間枠：baseline, week 2, week 3
|
Changes in ceramides blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Leptin
時間枠：baseline, week 2, week 3
|
changes in Leptin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Adiponectin
時間枠：baseline, week 2, week 3
|
Changes in Adiponectin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Glucagon-like Peptide-1 (GLP-1)
時間枠：baseline, week 2, week 3
|
changes in GLP-1 blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Resistin
時間枠：baseline, week 2, week 3
|
Changes in Resistin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
|
Serotonin
時間枠：baseline, week 2, week 3
|
changes in Serotonin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body Mass Index (BMI)
時間枠：baseline, week 3
|
change of BMI.
Body height was measured to an accuracy of +/-0.1cm.
BMI was calculated by dividing weight (kg) into height (squared m²).
|
baseline, week 3
|
|
HOMA-IR
時間枠：baseline, week 2, week 3
|
Changes of IR was calculated by the homeostasis model (HOMA-IR), proposed by Matthews et al.
HOMA-IR = (fasting insulin (mmol/L) × fasting glucose (µIU/ml))/22•5.
Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com),
and clinical assessments and measurements undertaken after 3 weeks.
Readings/assessment was performed at 3 weeks.
|
baseline, week 2, week 3
|
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。
スポンサー
捜査官
- 主任研究者：Amir Firouzjaei, Clinical PhD、Nanjing University of Traditional Chinese Medicine
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
2014年5月1日
一次修了 (実際)
2015年1月1日
研究の完了 (実際)
2015年4月1日
試験登録日
最初に提出
2015年4月21日
QC基準を満たした最初の提出物
2015年5月5日
最初の投稿 (見積もり)
2015年5月8日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年12月8日
QC基準を満たした最後の更新が送信されました
2016年10月14日
最終確認日
2016年10月1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。
metforminの臨床試験
-
Tan Tock Seng Hospital募集
-
Cairo Universityわからない