Informed Consent for Medically Supervised Weight Loss Program

I hereby consent to participate in the medically supervised weight loss program and receive any medications prescribed to me as part of this program. I understand that various FDA-approved, non-approved, and off-label prescription medications may be utilized to support weight loss, appetite suppression, metabolic enhancement, or related purposes.

Your Role:
Your success will depend upon your commitment to understanding and fulfilling your obligations during treatment. It is essential that you be willing to:
1. Provide honest and complete answers to questions about your health, weight problem, eating activity, and lifestyle patterns so your healthcare professional can better understand how to help you.
2. Devote the time needed to complete and comply with the course of treatment your health professional has outlined for you, including assessment, treatment, and maintenance phases.
3. Work with your healthcare professional and others who may participate in helping you manage your weight loss, including keeping a daily diary, attending your appointments regularly if appropriate, and following your diet and exercise prescription.
4. Allow your healthcare professional to share information with your personal physician.
5. Make and keep follow-up appointments with your physician and have any blood tests taken or any other diagnostic measures made that your physician may deem necessary during your course of treatment.
6. Follow your exercise program within the guidelines given to you by your healthcare professional and your physician.
7. Advise the clinic staff on ANY concerns, problems, complaints, symptoms, or questions, even if you may think it is not terribly important, so the physician can determine if you should be seen more often. Keeping the center informed of any questions or symptoms you have affords the best chance of intervening before a problem becomes serious.

Potential Benefits:
– Medically significant weight loss (usually about 10 percent of initial weight, or as an example, losing 20 pounds from 200 pounds starting weight)
– Improved medical conditions like hypertension, high cholesterol, diabetes
– Increased energy levels and mobility
– Enhanced quality of life

Potential Risks and Side Effects:
I understand that all medications, including those used for weight loss, carry potential risks and side effects. These may include but are not limited to:

Common Side Effects: Nausea, vomiting, diarrhea, constipation, abdominal pain/cramps, dry mouth, headache, dizziness, fatigue, insomnia, injection site reactions.

Serious Side Effects: Gallbladder disease, pancreatitis, cardiovascular effects, primary pulmonary hypertension, kidney problems, vision changes, allergic reactions, addiction/abuse potential with certain medications.

Risks Associated with GLP-1 Medications and Endoscopy Procedures:
If you are taking GLP-1 medications such as Semaglutide & Tirzepatide for weight loss or diabetes management, it is important to inform your healthcare provider if you are scheduled for an endoscopy procedure. These medications may increase your risk of aspiration pneumonia during the procedure due to their effect on slowing digestion. Aspiration pneumonia occurs when food, liquids, or saliva get sucked into the airway, potentially leading to choking and even death. To minimize this risk, you should communicate with your healthcare team well in advance of the procedure to discuss the appropriate course of action, which may include temporarily stopping the medication. Failure to disclose the use of GLP-1 medications before an endoscopy procedure may result in unnecessary and potentially life-threatening complications.

I will promptly report any concerning side effects to my provider. If I experience severe or life-threatening effects, I will seek immediate medical attention.

Other Risks:
– Binge eating episodes may temporarily increase on a calorie-restricted diet.
– Potential for weight regain after stopping the program.
– Rare risk of sudden death in those with morbid obesity and serious medical conditions.

I understand that weight loss medications are most effective when combined with lifestyle changes like dietary modifications and increased physical activity. I commit to following the full prescribed treatment plan, including attendance at follow-up appointments.

Medications:
Below is a list of some, but not all, medications that could be used as part of your weight loss treatment plan, along with a list of their potential benefits & risks:

1. Compounded Semaglutide:
– Use: Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist approved for chronic weight management in overweight/obese adults.
– Benefits: Promotes feeling of fullness, slows gastric emptying, reduces appetite. May improve glycemic control and cardiovascular risk factors.
– Common Side Effects: Nausea, vomiting, diarrhea, constipation, abdominal pain, decreased appetite, dizziness, fatigue, headache.
– Serious Side Effects: Pancreatitis, gallbladder disease, kidney problems, low blood sugar, vision changes, allergic reactions like anaphylaxis.
– Contraindications: Personal/family history of medullary thyroid cancer or MEN 2, hypersensitivity to semaglutide.
– Warnings: Not for patients with severe renal impairment. May increase risk of diabetic retinopathy. Use caution with history of pancreatitis.

2. Compounded Tirzepatide:
– Use: Tirzepatide is a dual GIP/GLP-1 receptor agonist approved as an adjunct to diet/exercise for chronic weight management.
– Benefits: Reduces appetite/food intake, promotes feeling of fullness, may improve glycemic control and cardiovascular risk factors.
– Common Side Effects: Nausea, vomiting, diarrhea, constipation, abdominal pain, decreased appetite, indigestion, fatigue.
– Serious Side Effects: Pancreatitis, gallbladder problems, kidney issues, hypoglycemia, vision changes, allergic reactions.
– Contraindications: Personal/family medullary thyroid cancer or MEN 2 syndrome, hypersensitivity to tirzepatide.
– Warnings: Not recommended with severe renal impairment or end-stage renal disease. May increase diabetic retinopathy risk.

3. Compounded Phentermine:
– Use: Phentermine is an amphetamine-derivative appetite suppressant approved for short-term (≤12 weeks) weight loss adjunct.
– Benefits: Reduces appetite and food intake through effects on the central nervous system.
– Common Side Effects: Increased heart rate, elevated blood pressure, insomnia, dry mouth, dizziness, constipation.
– Serious Side Effects: Cardiovascular effects like arrhythmias, primary pulmonary hypertension, addiction/abuse potential.
– Contraindications: Advanced cardiovascular disease, uncontrolled hypertension, hyperthyroidism, agitated states, drug abuse history.
– Warnings: Not recommended for long-term use due to potential for tolerance/dependence. Use caution with other CNS stimulants.

4. Lipotropic Injectables:
– Use: Lipotropic injectable compounds contain a combination of vitamins, minerals, and lipotropic agents (compounds that help remove fat from the liver) that are administered by injection to support weight loss efforts.
– Benefits: May increase metabolism and fat burning, support liver health and fat removal from the liver, provide a concentrated dose of essential nutrients involved in fat metabolism.
– Common Side Effects: Pain, redness, bruising at injection site, nausea, diarrhea, stomach cramps, fatigue, headache, dizziness, skin flushing.
– Serious Side Effects: Allergic reactions or anaphylaxis, interactions with other medications, liver or kidney damage if used long-term without monitoring.
– Contraindications: Pregnancy or breastfeeding, acute liver disease or liver failure, bleeding disorders, allergies to any components.
– Warnings: Not recommended for long-term use beyond 12 weeks without monitoring labs, use caution in those with liver or kidney disease, may interact with blood thinners, insulin, and certain medications, avoid injecting into muscles due to risk of injury.

Potential Side-Effects Expanded:

1. Reduced Weight:
When you reduce the number of calories you eat to a level lower than the number of calories your body uses in a day, you lose weight. In addition, your body makes some other adjustments in physiology. Some of these are responsible, in some participants for rapid improvements in blood pressure and blood sugar; other adjustments may be experienced as temporary side effects or discomforts. These may include:
– An initial loss of body fluid through increased urination
– Momentary dizziness
– A reduced metabolic rate or metabolism
– Sensitivity to cold
– A slower heart rate
– Dry skin
– Fatigue
– Diarrhea or constipation
– Bad breath
– Muscle cramps
– A change in menstrual pattern
– Dry and brittle hair or hair loss


These responses are temporary and resolve when calories are increased after the period of weight loss.

2. Reduced Potassium Levels:
The calorie level you should be consuming is 800 or more calories per day. Low potassium levels can cause serious heart irregularities. When someone has been on a reduced calorie diet, a rapid increase in calorie intake, especially overeating or binge-eating, can be associated with bloating, fluid retention disturbances in salt and mineral balance, or gallbladder attacks and abdominal pain. For these reasons, following a careful diet and gradually increasing calories after weight loss is essential.

3. Gallstones:
Overweight people develop gallstones at a rate higher than normal weight individuals. The occurrence of symptomatic gallstones (pain, diagnosed stones, and/or surgery) in individuals 30 percent or more over desirable body weight (50 pounds or more overweight) not undergoing current treatment for obesity is estimated to be 1 in 100 annually, and for individuals who are 0-30 percent overweight, about one-half that rate, or 1 in 200 annually. It is possible to have gallstones and not know it. One study of individuals entering a weight loss program showed that as many as 1 in 10 had silent gallstones at the onset. As body weight and age increase, so do the chances of developing gallstones. These chances double for women, women using estrogen, and smokers. Losing weight, especially rapidly, may increase the chances of developing stones or sludge and/or increasing the size of existing stones within the gallbladder. Should any symptoms develop (the most common are fever, nausea and a cramping pain in the right upper abdomen or if you know or suspect that you may already have gallstones), let your physician and healthcare professional know immediately. Gallbladder problems may require medication or surgery to remove the gallbladder, and, less commonly, may be associated with more serious complications of inflammation of the pancreas or even death.

4. Pancreatitis:
Pancreatitis, or an infection in the bile ducts, may be associated with the presence of gallstones and the development of sludge or obstruction in the bile ducts. The symptoms of pancreatitis include pain in the right upper abdominal area, nausea, and fever. Pancreatitis may be precipitated by binge-eating or consuming a large meal after a period of dieting. Also associated with pancreatitis are long-term abuse of alcohol and the use of certain medications and increased age. Pancreatitis may require surgery and may be associated with more serious complications and death.

5. Pregnancy:
If you become pregnant, report this to your healthcare professional and physician immediately. Your diet must be changed promptly to avoid further weight loss because a restricted diet could be damaging for a developing fetus. You must take precautions to avoid becoming pregnant during the course of weight loss.

6. Binge Eating Disorders:
Binge eating disorder is defined as the habitual, uncontrolled consumption of a large amount of food in a short period of time. Participation in a calorically restricted diet has been shown in one study to increase binge eating episodes temporarily. Several other studies demonstrated reduced episodes of binge eating following a calorie deficit and portion-controlled diet. Extended binge eating episodes are associated with weight gain.

7. Risk of Weight Regain:
Obesity is a chronic condition, and the majority of overweight individuals who lose weight have a tendency to regain all or some of it over time. Factors which favor maintaining a reduced body weight include regular physical activity, adherence to a restricted calorie, low fat diet, and planning a strategy for coping with weight regain before it occurs. Successful treatment may take months or even years. Medical studies of calorie deficit/portion-controlled diets (including modified fasting) have shown varying results for the percentage of patients who maintain weight loss. In some studies, the percentage has been fewer than 5% of the patients after five years. A group of patients who have been followed for 3 years show that patients have maintained about one half of initial weight loss. Additionally, if you have had fluctuations in your weight in the past, it may be more difficult to maintain the weight you lose during and after this program.

8. Sudden Death:
Patients with morbid obesity, particularly those with serious hypertension, coronary artery disease, or diabetes mellitus, have a statistically higher chance of suffering sudden death when compared to normal weight people without such medical problems. Rare instances of sudden death have occurred while obese patients were undergoing medically supervised weight reduction, though no cause and effect relationship with the diet has been established. The possibility cannot be excluded that some tiredness, psychological problems, medication allergies, high blood pressure, rapid heart rate, and heart irregularities. Less common, but more serious, risks are primary pulmonary hypertension and valvular heart disease. These and other possible risks could, on occasion, be serious or fatal.

9. Resale of Products:
Products and medicines purchased through this weight management program, including multivitamins, are intended to be sold through medically supervised weight management programs. By signing this Informed Consent, you agree that you will not resell any of the weight loss products purchased through this weight management program.

The possibility always exists in medicine that the combination of any significant disease with methods employed for its treatment may lead to previously unobserved or unexpected ill effects, including death. Should one or more of these conditions occur, additional medical or surgical treatment may be necessary. In addition, it is conceivable that other side effects could occur that have not been observed to date.

I acknowledge there are potential risks with any medication, and I release my provider from liability arising from the proper use of prescribed weight loss medications, except in cases of negligence.

I have read this consent fully, had my questions answered satisfactorily, and voluntarily consent to participate in this physician-supervised weight loss program and take any prescribed medications.

Peptides are small chains of amino acids that can have biological activity. They are mostly naturally occurring.

Some peptides are FDA-approved for the treatment of certain diseases. Other peptides used clinically are prepared by duly registered compounding pharmacies complying with all state and federal laws.

Peptides can be administered in various presentations, including but not limited to oral, intravenous, subcutaneous, intramuscular, and intranasal routes.

Understanding this, I hereby acknowledge and consent to the following:

I understand that the use of these peptides is not necessarily approved for my medical conditions and that my physician is providing this, following the principles of the practice of medicine and the laws regulating compounding pharmacies, as a complement to my current treatments.

As with any other drug, peptide therapies can have side effects, including but not limited to:
Nausea
Vomiting
Fever
Injection site reactions (pain, rash, bleeding)
Allergies, including life-threatening allergies

Additional side effects not listed may also occur
I further understand that peptide therapy is being used as part of an integrative treatment approach.

The FDA recently added AOD, BPC, CJC, Dihexa, DSIP, Epitalon, GHK-Cu, GHRP-2, GHRP-6, Ibutamoren, Ipamorelin, Kisspeptin, KPV, Melanotan II, MOTS-C, Selank, Semax, TA-1, and TB-4 to Category 2 in their list of bulk drug substances under Section 503A of the Food, Drug & Cosmetic Act. This indicates that these peptides have “significant safety risks.”

I understand that it is my responsibility to inform my primary care physician about the peptide therapy I am receiving at Matrix Hormones and to discuss any potential interactions with my current medications or treatments.

I understand that I have the right to discontinue peptide therapy at any time, and I will inform Matrix Hormones of my decision to do so.

Having read this, I hereby acknowledge that I am voluntarily undergoing peptide therapy and that I hereby relieve Matrix Hormones of any legal responsibility regarding side effects or complications that may occur due to receiving peptide therapies.

I certify that I will promptly notify Matrix Hormones if any concerns or side effects occur. I also understand that Matrix Hormones is not responsible for any manufacturing issues related to these peptides, such as sterility and potency, which are the sole responsibility of the compounding pharmacy preparing them.

By signing below, I acknowledge that I have read, understood, and agree to the terms and conditions outlined in this document. I have had the opportunity to ask questions and have received satisfactory answers.

This document is intended to provide information about peptide therapy and its potential risks. It should not be considered a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or treatment.