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Yoga for the Management of HIV-Metabolic Syndromes 第IV相・フェーズ4 60 生活習慣

完了
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」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 NCT00627380 は 治療 の研究で、HIV感染症、HIV Metabolic Cardiovascular Syndrome、HIV Lipodystrophy、HIV Metabolic Syndromes、高血圧 を対象とした 第IV相・フェーズ4 介入研究 臨床試験 でした。現在は 完了 です。2005年11月1日 に開始し、60 名の参加者 が参加しました。この試験は セントルイスのワシントン大学 によって主導され、2009年6月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2010年7月26日 です。
概要
We are testing the safety and efficacy of a 16-wk yoga lifestyle intervention on oral glucose tolerance, fasting lipid/lipoprotein levels, body composition, cardiovascular function, quality of life, CD4+ T-cell counts and viral load in HIV-infected men and women with components of The Metabolic Syndrome. We hypothesize that a yoga lifestyle intervention will improve metabolic, anthropometric, cardiovascular disease p...もっと見る
詳細説明
Very few safe, effective, and novel treatments for metabolic syndromes that develop in HIV-infected people exist. These metabolic syndromes may increase cardiovascular disease risk in HIV-infected people and may reduce their quantity and quality of life. Practicing a yoga lifestyle intervention may provide a safe, effective and novel therapy for HIV metabolic syndromes, but this alternative form of therapy has not be...もっと見る
公式タイトル

Yoga for the Management of HIV-Metabolic Syndromes

疾患名
HIV感染症HIV Metabolic Cardiovascular SyndromeHIV LipodystrophyHIV Metabolic Syndromes高血圧
刊行物
この臨床試験について発表された科学記事と研究論文：
その他の研究識別子
NCT番号
NCT00627380
開始日
2005-11
最終更新日
2010-07-26
終了予定日
2009-06
目標参加者数
60
試験の種類
介入研究
治験の相・段階
第IV相・フェーズ4
状況
完了
キーワード
HIV
AIDS
insulin resistance
diabetes
dyslipidemia
visceral adiposity
subcutaneous adipose wasting
cardiovascular disease
hypertension
endothelial function
quality of life
Complementary Therapies
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
プラセボ対照薬STOC
Standard of care arm continues to receive standard of care treatment for HIV, but does not receive any new treatment/intervention or change in anti-HIV medications. Runs parallel to experimental group. At the end of this 16-wk control period, participants are invited to crossover into the experimental group
標準治療
Participants are observed/followed for 16 weeks during which lifestyle and medication changes are discouraged, unless medically necessary.
実験的YOGA
Yoga lifestyle intervention administered by certified yoga instructor.
Yoga lifestyle intervention
Sixteen weeks of 2-3 yoga sessions per week, 1.5 hrs per session administered by a certified yoga instructor. Sessions include breathing exercises and yoga postures/positions.
主要評価項目
評価指標指標の説明時間枠
The primary efficacy outcome is a metabolic parameter: insulin integrated area under the curve (AUC) during the oral glucose tolerance test.
Baseline and week 16
副次評価項目
評価指標指標の説明時間枠
Fasting lipid/lipoprotein levels.
Baseline and week 16
Body composition: visceral and subcutaneous adipose tissue areas (VAT, SAT), trunk/limb adipose ratio.
Baseline and week 16
Cardiovascular disease risk: Framingham 10-yr CVD risk calculation
Baseline and week 16
Quality of life: SF36 MOS
Baseline and week 16
Safety: CD4 count and plasma HIV RNA
Baseline and week 16
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
  • HIV-infected volunteers must have dyslipidemia (fasting serum LDL-cholesterol >100mg/dL, or
  • triglycerides >200mg/dL, or
  • HDL-cholesterol <40mg/dL (men) or <50mg/dL (women), or
  • impaired glucose tolerance (fasting blood glucose 100-140mg/dL or
  • fasting insulin 13-45µU/mL or 2hr glucose during the oGTT 140-200mg/dL),or
  • central adiposity (waist circumference >102 cm (40inches in men) or >88cm (35inches in women)
  • The purpose is to identify and enroll participants with a clear proatherogenic lipid profile
  • increased CVD risk
  • abdominal adiposity, and fasting glucose intolerance or insulin resistance
  • but not type 2 diabetics who have normalized their blood sugars using glucose-lowering agents. If a type 2 diabetic uses a glucose-lowering medication, but they are still insulin resistant/glucose intolerant (by above criteria), they are eligible to participate, because we are testing the added benefits of yoga therapy on a defined dysmetabolic syndrome in participants who are stable on the standard-of-care for these metabolic syndromes, and this includes glucose- and lipid-lowering agents
  • These criteria must be met, even in volunteers receiving glucose- or lipid-lowering agents, so that we enroll participants who have developed metabolic syndromes that are not normalized by traditional pharmacologic approaches
  • Volunteers receiving glucose- or lipid-lowering agents who have normalized their lipid, glucose and insulin levels below these defined limits, are not eligible to enroll.

Additional Inclusion Criteria.

  • 18-70 years old.

  • Plasma HIV RNA <15,000 copies/ml for previous 3months.

  • CD4 count >200 c/µL for previous 3 months.

  • Stable HIV RNA level and stable CD4 count for at least the past 3 months. Some HIV-infected people can accomplish this while not receiving HAART (eg. long term non-progressors) and will be included. But, most of the participants will be on a HAART regimen that includes either 2 NRTIs + NNRTI, or 2NRTIs + PI, or NRTI+NNRTI+PI

  • "Normal" blood chemistries for at least 1 month prior to enrollment:

    • platelet count >30,000/mm3
    • absolute neutrophil count >750/mm3
    • transaminases <5x the upper limit of normal
    • creatinine <3x the upper limit of normal
    • albumin >30g/L

  • Chronic hepatitis B infection (HB surface antigen positive). Active hepatitis C infection (detectable Hep C RNA). Those who have cleared hepatitis B or C infection are eligible.
  • Diabetes \[fasting glucose \>140 mg/dL, or fasting insulin \>45 µU/mL, or 2-hr glucose \>200mg/dL\].
  • History of diabetes mellitus that pre-dates HIV-infection. Medications or agents that regulate glucose or lipid metabolism (e.g., insulin-sensitizers, insulin-secretagogues, HMG-CoA reductase inhibitors ('statins'), fibrates, niacin) are permitted. A large percentage of ACTU subjects and ID Clinic patients receiving RTV-boosted regimens are also receiving lipid-lowering agents. Excluding them might significantly reduce the pool of potential enrollees. The glucose- or lipid-lowering agent and dose must be stable for at least 3 months prior to screening. Additionally, volunteers taking glucose-or lipid-lowering agents must still have dyslipidemia and impaired glucose tolerance criteria (above). If they are taking these agents and have 'normalized' their lipids/lipoproteins and hyperinsulinemia, then they are not eligible
  • Gestational diabetes, pregnancy, or nursing mothers. Menstruating women must have a negative urine pregnancy test within 14 days prior to DEXA testing (minor radiation exposure from DEXA). To control for potential metabolic effects of alterations in female hormones during the menstrual cycle, all menstruating women will be tested during the follicular phase.
  • Hypogonadism \[total testosterone \<200ng/dL (men) or \<15ng/dL (women)\]; thyroid disorder \[TSH \<0.2 or \>12µIU/mL\]; hypercortisolemia \[morning cortisol \>22µg/dL\]. Replacement testosterone or thyroid hormones or human growth hormone to normalize abnormal levels is acceptable, as long as treatment has been stable, and blood testosterone, TSH or IGF-1 levels are within the normal range.
  • Unwilling or unable to attend supervised yoga sessions 3days/wk provided by Brentwood Center for Health at the Connectcare Clinic. Any condition that might be contraindicated for yoga therapy (disabling neuromuscular or musculoskeletal injury/disorder)
  • History of serious cardiovascular disease; MI, unstable angina, heart failure, congenital heart disease, coronary artery disease, resting ST-segment depression >1mm, coronary artery bypass graft, stroke, sinus tachycardia, arrhythmias, premature atrial or ventricular contractions, claudication. Bundle branch block is exclusionary because it limits the interpretability of the resting/exercise ECG. Cardiovascular contraindications to maximal exercise testing
  • Anticipated change in anti-HIV medications or other medications that affect metabolism, within the next 4months
  • Well-trained athletes (defined as >3 exercise training exposures/week; >30min regimented exercise/exposure maintained for at least the prior 4 weeks)
  • Active substance abuse (eg, alcoholism, cocaine, heroin, crack, methamphetamine, phencyclidine)
  • Active secondary infection or a significant change in chronic suppressive therapy for an opportunistic infection during 1 month prior to enrollment
  • New serious systemic infection during the 3 weeks prior to enrollment
  • Recent episode of hyperlactatemia or lactic acidosis, esp. with rapid weight loss
  • Chronic renal insufficiency/failure or other comorbid conditions (eg. cancer, COPD) that alter metabolism
  • Pancreatitis, celiac disease, or cirrhosis
  • Inadequate macronutrient or energy intake, or malabsorptive disorder as determined by the research dietician
  • Dementia or any condition that would prevent voluntary informed consent or compliance
  • Other compounds or blinded investigational new drugs that might affect metabolism or confound data interpretation (eg. RU486, interleukin therapy, or cytokine-receptor antagonist)
  • Oral glucocorticoid or corticosteroid use within the previous 3 months
Washington University School of Medicine logoセントルイスのワシントン大学462 件のアクティブな治験を探索
National Center for Complementary and Integrative Health (NCCIH) logoNational Center for Complementary and Integrative Health (NCCIH)
連絡先情報がありません。
1 1カ国の場所

Missouri

Washington University School of Medicine, St Louis, Missouri, 63110, United States