Diet and Exercise Intervention in Type 2 Diabetes (LID)
2022年4月13日 更新者:Washington University School of Medicine
The purpose of this study is to determine the effect of a worksite-based intensive lifestyle therapy intervention (weight loss with exercise training) on blood sugar control in people with obesity and type 2 diabetics.
調査の概要
詳細な説明
The purpose of this study is to conduct a randomized, controlled trial in people with obesity and type 2 diabetes to determine the therapeutic effects of intensive lifestyle therapy conducted at the worksite compared to standard care on: i) the major factors involved in the pathogenesis of type 2 diabetes (insulin sensitivity, β-cell function and the metabolic response to glucose ingestion), ii) body composition; iii) physical function (cardiorespiratory fitness and muscle strength); iv) and the potential cellular mechanisms that can affect insulin action in muscle and adipose tissue (fat).
研究の種類
介入
入学 (実際)
18
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
-
-
Missouri
-
Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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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
25年~68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 25-68 yrs old
- BMI 27.0-50.0 kg/m²
- Diagnosis of type 2 diabetes based on HbA1C>6.5% or results of an oral glucose tolerance test or current use of anti-diabetic medications
- HbA1C ≤9.5 %.
- Work at Washington University in St. Louis, Barnes Jewish Hospital, St. Louis Children's Hospital, Shriners, St. Louis College of Pharmacy, Central Institute for the Deaf, Rehabilitation Institute of St. Louis, and/or any institutions affiliated with these.
Exclusion Criteria:
- Any change in diabetes medication in previous 3 months
- Treated with >0.5 units of insulin/kg body weight per day
- Unstable weight (>2% change during the last 2 months before entering the study)
- History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or New York Heart Association class III heart failure (patients with marked limitation of activity and who are comfortable only at rest) or IV heart failure (patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity).
- Evidence of serious cardiac abnormalities during exercise stress testing that increase cardiac risk of initiating an exercise program.
- Creatinine >1.5 mg/dL
- Microalbuminuria; spot urine albumin:creatinine ratio >50 (50 μg albumin/mg creatinine)
- Coagulation disorders
- Anemia (Hemoglobin <10.0 g/dL)
- Liver enzymes (ALT and AST) ≥3 times the upper limit of normal
- Uncontrolled proliferative diabetic retinopathy
- Severe peripheral neuropathy diagnosed by monofilament testing
- Severe organ dysfunction
- Pregnant or breastfeeding
- Participating in regular exercise (>1 h of structured exercise/week)
- Joint replacement within the last year
- Smokes tobacco
- Severe lactose intolerance
- Take any medication that might interfere with interpretation of the metabolic studies
- Unable or unwilling to follow the study protocol or for any reason the research team believes the volunteer is not an appropriate candidate for this study, including non-compliance with screening appointments or previous medical visits.
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
他の:Standard Care
Participants randomized to this arm will receive dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines.
|
After receiving dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines participants will meet approximately every month for about 7 months with a study team member to record body weight, review diet and physical activity behaviors, and document medication use.
Participants will continue their routine medical management, including regular clinic visits with their personal physician and/or diabetes educator during their participation in this study.
Any changes medications will made by the participants' personal physician(s).
|
実験的:Intensive Lifestyle intervention
Participants randomized to this arm will be participate in weekly dietary and behavioral education session in addition to four 60-min supervised exercise training sessions per week for 8 months.
All dietary and- behavioral education and exercise training sessions will be conducted at the worksite.
|
Participants will be instructed to consume ~500 kcal/day less than their calculated estimated total daily energy requirements.
The supervised exercise program will include both endurance and resistance exercise training sessions.
The doses of diabetes medications will be adjusted by study physicians every 1-2 weeks, as needed to avoid hypoglycemia.
|
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 |
---|---|---|
Skeletal muscle insulin sensitivity
時間枠:7-8 months
|
Skeletal muscle insulin sensitivity will be calculated as the glucose disposal rate per kg fat-free mass divided by plasma insulin during a hyperinsulinemic-euglycemic clamp procedure.
|
7-8 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Liver insulin sensitivity
時間枠:7-8 months
|
Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index.
|
7-8 months
|
Adipose tissue insulin sensitivity
時間枠:7-8 months
|
Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index.
|
7-8 months
|
β-cell function
時間枠:7-8 months
|
β-cell function will be assessed from a modified oral glucose tolerance test
|
7-8 months
|
Insulin clearance
時間枠:7-8 months
|
Insulin clearance will be assessed from a modified oral glucose tolerance test
|
7-8 months
|
Diabetes remission
時間枠:7-8 months
|
Remission of type 2 diabetes will be defined as HbA1c <6.0% without the use of diabetes medications use of diabetes medications.
|
7-8 months
|
Cardiorespiratory fitness
時間枠:7-8 months
|
Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion.
|
7-8 months
|
Muscle strength
時間枠:7-8 months
|
Muscle strength will be assessed as the total maximal weight lifted during the 1 repetition maximum tests for leg press, knee flexion, seated row, and chest press exercises.
|
7-8 months
|
Whole-body fat mass
時間枠:7-8 months
|
Total body fat mass will be assessed by dual-energy X-ray absorptiometry.
|
7-8 months
|
Whole-body fat-free mass
時間枠:7-8 months
|
Fat-free mass will be assessed by dual-energy X-ray absorptiometry.
|
7-8 months
|
Appendicular lean mass
時間枠:7-8 months
|
Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry.
|
7-8 months
|
Intra-abdominal adipose tissue volume
時間枠:7-8 months
|
Intra-abdominal adipose tissue volume will be determined by using magnetic resonance imaging.
|
7-8 months
|
Intrahepatic triglyceride content
時間枠:7-8 months
|
Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy.
|
7-8 months
|
Plasma adipokine concentrations
時間枠:7-8 months
|
Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory.
|
7-8 months
|
Transcriptome in muscle and adipose tissue
時間枠:7-8 months
|
The transcriptome (all RNA that are responsible for making proteins from DNA templates) will be evaluated by using RNA sequencing techniques.
|
7-8 months
|
Skeletal muscle mitochondrial metabolites
時間枠:7-8 months
|
The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry.
|
7-8 months
|
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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Yoshino M, Yoshino J, Smith GI, Stein RI, Bittel AJ, Bittel DC, Reeds DN, Sinacore DR, Cade WT, Patterson BW, Cho K, Patti GJ, Mittendorfer B, Klein S. Worksite-based intensive lifestyle therapy has profound cardiometabolic benefits in people with obesity and type 2 diabetes. Cell Metab. 2022 Oct 4;34(10):1431-1441.e5. doi: 10.1016/j.cmet.2022.08.012. Epub 2022 Sep 8.
- Mittendorfer B, Patterson BW, Smith GI, Yoshino M, Klein S. beta Cell function and plasma insulin clearance in people with obesity and different glycemic status. J Clin Invest. 2022 Feb 1;132(3):e154068. doi: 10.1172/JCI154068.
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)
2013年10月1日
一次修了 (実際)
2016年7月1日
研究の完了 (実際)
2016年7月1日
試験登録日
最初に提出
2013年10月14日
QC基準を満たした最初の提出物
2013年10月30日
最初の投稿 (見積もり)
2013年11月6日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月15日
QC基準を満たした最後の更新が送信されました
2022年4月13日
最終確認日
2022年4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。
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