Type 2 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are between 60 and 80 years old (male or female)
• People who have pre-diabetes or type 2 diabetes and are only managing it with certain oral medications (DPP-4 inhibitors, Sulfonylureas, and/or Metformin), with a blood sugar control level (A1C) below 8.0 — or people who have normal blood sugar levels and serve as a comparison group (confirm with trial site for which group applies)
• People whose kidneys are functioning at an adequate level, based on a blood test done at the screening visit (confirm with trial site)
• People whose triglyceride (a type of blood fat) level is below 350 mg/dl and whose LDL ("bad") cholesterol is at or below 150 mg/dl at screening
• People who have not smoked, used tobacco, used nicotine products, or used vaping devices in the past 3 months
• People who are willing to follow all study requirements, including consuming the study product as directed, following the activity plan, and completing any required paperwork
• People who have voluntarily signed a consent form that has been approved by an ethics review board, and have agreed to the privacy terms required by the study

Who may not be able to join:

• People who have type 1 diabetes
• People with a BMI above 40.0 kg/m²
• People who are currently actively trying to lose weight or make lifestyle changes
• People who have a history of pressure ulcers (sores caused by prolonged pressure on the skin)
• People who have a history of deep vein thrombosis (blood clots in the veins), pulmonary embolism (blood clot in the lungs), or any known condition affecting blood clotting or bleeding
• People with a history of bleeding in the stomach, intestines, or brain
• People with a history of stroke or a related brain circulation event
• People who have experienced a major physical injury within the past 3 months
• People who have a low platelet count (affecting blood clotting) or high potassium levels in their blood at screening (the trial site may allow a repeat test at the investigator's discretion)
• People with uncontrolled or poorly managed high or low blood pressure at screening
• People with a thyroid-stimulating hormone (TSH) level at or above 10 mIU/L, which may indicate a thyroid problem
• People who currently have an infection being treated with prescription antibiotics or antivirals, or who have been hospitalised for infection, or who have used oral or injected steroid medications (not including inhaled or skin-applied steroids) in the past 3 months
• People who are currently taking anti-inflammatory medications (such as ibuprofen, naproxen, Aleve, or Motrin — including over-the-counter versions), or who have taken them within 1 week before screening
• People who have had surgery requiring more than 2 days in hospital within the past month
• People who have an active cancer or an autoimmune disease
• People with significantly impaired liver function or liver enzyme levels that are 2.5 times or more above the normal range (mild, symptom-free fatty liver is acceptable)
• People who have a chronic contagious infectious disease such as active tuberculosis, Hepatitis B or C, or HIV
• People who are amputees or who have a partial or full artificial limb
• People who have had a major heart or cardiovascular event (such as a heart attack or stroke) within the past 6 months, who have a history of heart failure, or who show signs of heart disease on an ECG (heart tracing) done at screening
• People with a history of, or who currently have, severe uncontrolled diarrhoea, nausea, or vomiting
• People with blockages or diseases of the digestive tract, including inflammatory bowel disease, short bowel syndrome, severe acid reflux disease (stage III or above), gastroparesis, peptic ulcer disease, coeliac disease, diverticulitis, ischemic colitis, or people who have had bariatric (weight loss) surgery
• People who are unable to avoid alcohol completely during the pre-bed rest and bed rest portions of the study, or who are unable to limit alcohol to no more than one small glass of wine or one bottle of beer per day during the recovery portion
• People who are unable to stop taking certain supplements, herbal products, or medications that may affect blood sugar, muscle, body weight, or blood clotting — including steroids, growth hormone, marijuana, certain amino acid supplements, and weight loss supplements — starting one week before enrolment and throughout the entire study (confirm with trial site for the full list)
• People with a score below 21 on a standard memory and thinking assessment (Mini-Mental State Examination)
• People who have metal implants, devices, or other metal-containing objects in their body that would make MRI scanning unsafe, or who have certain metal-containing tattoos
• People who are unable to undergo MRI or DEXA bone/body composition scans due to physical size, claustrophobia, or other limitations, in the investigator's judgment
• People who have an allergy or sensitivity to lidocaine (a local anaesthetic)
• People who have an allergy or sensitivity to heparin, enoxaparin, or other low-molecular-weight heparin medications (blood thinners used in the study)
• People with a history of allergy to pork products, or to any ingredient in the low-molecular-weight heparin used in the study
• People with a history of a condition called heparin-induced thrombocytopenia (a reaction to heparin that lowers platelet counts)
• People with low haemoglobin (a measure of red blood cells) — below 10.0 g/dL for women or below 11.0 g/dL for men — or who show signs of anaemia in the investigator's opinion
• People who are taking other medications that are known to interact with low-molecular-weight heparin, including blood thinners, anti-platelet drugs, or anti-inflammatory medications
• People who have any condition that, in the investigator's opinion, could put them at risk or affect the reliability of study results
• People who experience cramping pain in the legs or difficulty walking (known as claudication symptoms)

Important: Always verify eligibility with the trial site directly before applying.